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Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (VIABLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02111577
Recruitment Status : Completed
First Posted : April 11, 2014
Results First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Sotio a.s.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Metastatic Castration-resistant Prostate Cancer
Interventions Biological: DCVAC/PCa
Biological: Placebo
Enrollment 1182
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description Combination therapy with dendritic cell vaccine for prostate cancer (DCVAC/PCa) and standard of care chemotherapy (docetaxel and prednisone) Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Period Title: Overall Study
Started 787 395
Completed 188 106
Not Completed 599 289
Reason Not Completed
Protocol Violation             2             0
Unable to tolerate leukapheresis             1             0
Failure to produce study treatment             6             0
Death             518             254
Medical monitor's decision (active hepatitis B)             1             0
Adverse Event             1             1
Withdrawal by Subject             51             23
Disease progression             0             1
Lost to Follow-up             19             10
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy Total
Hide Arm/Group Description Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone) Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator Total of all reporting groups
Overall Number of Baseline Participants 787 395 1182
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 787 participants 395 participants 1182 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
272
  34.6%
107
  27.1%
379
  32.1%
>=65 years
515
  65.4%
288
  72.9%
803
  67.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 787 participants 395 participants 1182 participants
68.0
(46 to 89)
69.0
(46 to 89)
68.0
(46 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 787 participants 395 participants 1182 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
787
 100.0%
395
 100.0%
1182
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 787 participants 395 participants 1182 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   0.6%
4
   1.0%
9
   0.8%
Native Hawaiian or Other Pacific Islander
1
   0.1%
0
   0.0%
1
   0.1%
Black or African American
26
   3.3%
19
   4.8%
45
   3.8%
White
733
  93.1%
358
  90.6%
1091
  92.3%
More than one race
4
   0.5%
3
   0.8%
7
   0.6%
Unknown or Not Reported
18
   2.3%
11
   2.8%
29
   2.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Hungary Number Analyzed 787 participants 395 participants 1182 participants
28 14 42
United States Number Analyzed 787 participants 395 participants 1182 participants
144 73 217
Czechia Number Analyzed 787 participants 395 participants 1182 participants
102 40 142
United Kingdom Number Analyzed 787 participants 395 participants 1182 participants
60 36 96
Belarus Number Analyzed 787 participants 395 participants 1182 participants
13 18 31
Portugal Number Analyzed 787 participants 395 participants 1182 participants
20 10 30
Spain Number Analyzed 787 participants 395 participants 1182 participants
18 14 32
Austria Number Analyzed 787 participants 395 participants 1182 participants
14 5 19
Latvia Number Analyzed 787 participants 395 participants 1182 participants
0 2 2
Netherlands Number Analyzed 787 participants 395 participants 1182 participants
29 19 48
Sweden Number Analyzed 787 participants 395 participants 1182 participants
4 1 5
Belgium Number Analyzed 787 participants 395 participants 1182 participants
20 11 31
Denmark Number Analyzed 787 participants 395 participants 1182 participants
2 0 2
Poland Number Analyzed 787 participants 395 participants 1182 participants
94 36 130
Italy Number Analyzed 787 participants 395 participants 1182 participants
19 3 22
Slovakia Number Analyzed 787 participants 395 participants 1182 participants
49 15 64
Bulgaria Number Analyzed 787 participants 395 participants 1182 participants
15 10 25
France Number Analyzed 787 participants 395 participants 1182 participants
18 12 30
Lithuania Number Analyzed 787 participants 395 participants 1182 participants
6 5 11
Serbia Number Analyzed 787 participants 395 participants 1182 participants
22 14 36
Germany Number Analyzed 787 participants 395 participants 1182 participants
92 51 143
Croatia Number Analyzed 787 participants 395 participants 1182 participants
18 6 24
Prostate-specific antigen   [1] 
Median (Full Range)
Unit of measure:  ng/L
Number Analyzed 786 participants 394 participants 1180 participants
46.35
(0.0 to 7500.0)
54.02
(0.1 to 5000.0)
47.87
(0.0 to 7500.0)
[1]
Measure Analysis Population Description: PSA available for 786 patients in the experimental arm (DCVAC/PCa) and 394 patients in the control arm (placebo)
1.Primary Outcome
Title Overall Survival, Intention-to-treat Population
Hide Description Overall survival is defined as the time from randomization until death due to any cause.
Time Frame From randomization to death due to any cause, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population definition: All randomized patients
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:

Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)

DCVAC/PCa: DCVAC/PCa concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). DCVAC/PCa was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of DCVAC/PCa was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.

Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator

Placebo: Placebo concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). Placebo was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of placebo was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.

Overall Number of Participants Analyzed 787 395
Median (95% Confidence Interval)
Unit of Measure: Months
23.9
(21.6 to 25.3)
24.3
(22.6 to 26.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and Eastern Cooperative Oncology Group (ECOG) score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.596
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.042
Confidence Interval (2-Sided) 95%
0.895 to 1.213
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.648
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.036
Confidence Interval (2-Sided) 95%
0.891 to 1.204
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival, Per Protocol Population
Hide Description Overall survival is defined as the time from randomization until death due to any cause.
Time Frame From randomization to death due to any cause, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description

Per protocol population definition:

A subset of all randomized patients characterized by the following criteria:

  • had at least 1 post-baseline efficacy assessment
  • did not have any major protocol violation that would affect the endpoints being assessed
  • received at least 8 doses of DCVAC/PCa or placebo
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 438 284
Median (95% Confidence Interval)
Unit of Measure: Months
29.7
(26.9 to 32.3)
26.7
(24.7 to 28.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.335
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.908
Confidence Interval (2-Sided) 95%
0.746 to 1.105
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.192
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.879
Confidence Interval (2-Sided) 95%
0.725 to 1.067
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival, Intention-to-treat Population, Abiraterone as Prior Therapy
Hide Description Overall survival is defined as the time from randomization until death due to any cause.
Time Frame From randomization to death due to any cause, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population definition: All randomized patients with abiraterone as prior therapy
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 187 103
Median (95% Confidence Interval)
Unit of Measure: Months
16.6
(14.9 to 19.7)
21.0
(16.6 to 24.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.312
Confidence Interval (2-Sided) 95%
0.976 to 1.762
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.283
Confidence Interval (2-Sided) 95%
0.961 to 1.712
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Overall Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy
Hide Description Overall survival is defined as the time from randomization until death due to any cause.
Time Frame From randomization to death due to any cause, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population definition: All randomized patients with enzalutamide as prior therapy
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 137 60
Median (95% Confidence Interval)
Unit of Measure: Months
15.2
(13.3 to 18.3)
21.4
(15.1 to 26.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.461
Confidence Interval (2-Sided) 95%
1 to 2.134
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.436
Confidence Interval (2-Sided) 95%
0.993 to 2.077
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide
Hide Description Overall survival is defined as the time from randomization until death due to any cause.
Time Frame From randomization to death due to any cause, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population definition: All randomized patients with neither abiraterone nor enzalutamide as prior therapy
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 546 271
Median (95% Confidence Interval)
Unit of Measure: Months
26.7
(25.2 to 28.8)
25.7
(23.8 to 28.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.501
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.938
Confidence Interval (2-Sided) 95%
0.779 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.512
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.781 to 1.131
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Radiological Progression-free Survival, Intention-to-treat Population
Hide Description Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Time Frame Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population definition: All randomized patients
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 787 395
Median (95% Confidence Interval)
Unit of Measure: Months
11.1
(11.0 to 11.4)
11.1
(10.8 to 11.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.886
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.863 to 1.136
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.992
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.001
Confidence Interval (2-Sided) 95%
0.875 to 1.145
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Radiological Progression-free Survival, Per Protocol Population
Hide Description Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.
Time Frame Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description

Per protocol population definition:

A subset of all randomized patients characterized by the following criteria:

  • had at least 1 post-baseline efficacy assessment
  • did not have any major protocol violation that would affect the endpoints being assessed
  • received at least 8 doses of DCVAC/PCa or placebo
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 438 284
Median (95% Confidence Interval)
Unit of Measure: Months
11.2
(11.1 to 11.7)
11.2
(11.0 to 11.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.994
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.001
Confidence Interval (2-Sided) 95%
0.847 to 1.184
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.982
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.002
Confidence Interval (2-Sided) 95%
0.851 to 1.18
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Time to PSA Progression, Intention-to-treat Population
Hide Description The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.
Time Frame Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population definition: All randomized patients
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 787 395
Median (95% Confidence Interval)
Unit of Measure: Months
10.5
(9.7 to 10.6)
10.6
(10.4 to 10.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.392
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.077
Confidence Interval (2-Sided) 95%
0.909 to 1.277
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.439
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.068
Confidence Interval (2-Sided) 95%
0.905 to 1.262
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Time to PSA Progression, Per Protocol Population
Hide Description The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.
Time Frame Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months
Hide Outcome Measure Data
Hide Analysis Population Description

Per protocol population definition:

A subset of all randomized patients characterized by the following criteria:

  • had at least 1 post-baseline efficacy assessment
  • did not have any major protocol violation that would affect the endpoints being assessed
  • received at least 8 doses of DCVAC/PCa or placebo
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 438 284
Median (95% Confidence Interval)
Unit of Measure: Months
10.5
(10.4 to 10.7)
10.6
(10.4 to 10.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.754
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.857 to 1.238
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.924
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.009
Confidence Interval (2-Sided) 95%
0.844 to 1.207
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Time to First Skeletal-related Event, Intention-to-treat Population
Hide Description

Skeletal-related events included:

  • Radiation therapy to bone
  • Pathologic bone fracture
  • Spinal cord compression
  • Surgery to bone
  • Change in antineoplastic therapy to treat bone pain
Time Frame Time from randomization to the date of the first skeletal-related event, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population definition: All randomized patients
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 787 395
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Not reached; insufficient number of participants with events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.732
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.918
Confidence Interval (2-Sided) 95%
0.563 to 1.497
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.713
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.913
Confidence Interval (2-Sided) 95%
0.561 to 1.485
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Time to First Skeletal-related Event, Per Protocol Population
Hide Description

Skeletal-related events included:

  • Radiation therapy to bone
  • Pathologic bone fracture
  • Spinal cord compression
  • Surgery to bone
  • Change in antineoplastic therapy to treat bone pain
Time Frame Time from randomization to the date of the first skeletal-related event, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description

Per protocol population definition:

A subset of all randomized patients characterized by the following criteria:

  • had at least 1 post-baseline efficacy assessment
  • did not have any major protocol violation that would affect the endpoints being assessed
  • received at least 8 doses of DCVAC/PCa or placebo
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 438 284
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Not reached; insufficient number of participants with events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.694
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.891
Confidence Interval (2-Sided) 95%
0.5 to 1.587
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.496 to 1.562
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population
Hide Description

Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.

Skeletal-related events included:

  • Radiation therapy to bone
  • Pathologic bone fracture
  • Spinal cord compression
  • Surgery to bone
  • Change in antineoplastic therapy to treat bone pain
Time Frame Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population definition: All randomized patients
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 787 395
Median (95% Confidence Interval)
Unit of Measure: Months
11.1
(10.9 to 11.3)
10.9
(10.5 to 11.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.111
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.895
Confidence Interval (2-Sided) 95%
0.781 to 1.027
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.184
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.913
Confidence Interval (2-Sided) 95%
0.798 to 1.044
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Time to Radiological Progression or Skeletal-related Event, Per Protocol Population
Hide Description

Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.

Skeletal-related events included:

  • Radiation therapy to bone
  • Pathologic bone fracture
  • Spinal cord compression
  • Surgery to bone
  • Change in antineoplastic therapy to treat bone pain
Time Frame Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of all randomized patients characterized by the following criteria:

  • had at least 1 post-baseline efficacy assessment
  • did not have any major protocol violation that would affect the endpoints being assessed
  • received at least 8 doses of DCVAC/PCa or placebo
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 438 284
Median (95% Confidence Interval)
Unit of Measure: Months
11.1
(11.0 to 11.5)
11.1
(10.8 to 11.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.939
Confidence Interval (2-Sided) 95%
0.795 to 1.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Unstratified
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.534
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.807 to 1.118
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Proportion of Patients With Skeletal-related Events, Intention-to-treat Population
Hide Description

Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.

Skeletal-related events included:

  • Radiation therapy to bone
  • Pathologic bone fracture
  • Spinal cord compression
  • Surgery to bone
  • Change in antineoplastic therapy to treat bone pain
Time Frame From randomization to the end of the study, up to 57 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population definition: All randomized patients
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 787 395
Measure Type: Number
Unit of Measure: Patients
43 26
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.485
Comments [Not Specified]
Method Log binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.845
Confidence Interval (2-Sided) 95%
0.528 to 1.355
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Proportion of Patients With Skeletal-related Events, Per Protocol Population
Hide Description

Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.

Skeletal-related events included:

  • Radiation therapy to bone
  • Pathologic bone fracture
  • Spinal cord compression
  • Surgery to bone
  • Change in antineoplastic therapy to treat bone pain
Time Frame From randomization to the end of the study, up to 57 months
Hide Outcome Measure Data
Hide Analysis Population Description

A subset of all randomized patients characterized by the following criteria:

  • had at least 1 post-baseline efficacy assessment
  • did not have any major protocol violation that would affect the endpoints being assessed
  • received at least 8 doses of DCVAC/PCa or placebo
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description:
Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone)
Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
Overall Number of Participants Analyzed 438 284
Measure Type: Number
Unit of Measure: Patients
28 20
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DCVAC/PCa With Standard of Care Chemotherapy, Placebo With Standard of Care Chemotherapy
Comments Stratified
Type of Statistical Test Superiority
Comments Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)
Statistical Test of Hypothesis P-Value 0.768
Comments [Not Specified]
Method Log binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.529 to 1.601
Estimation Comments [Not Specified]
Time Frame Up to 68 months. Adverse events (AEs) occurring after signing the informed consent until 30 days after the last dose of DCVAC/PCa or placebo were collected. Treatment-emergent AEs: Start date on or after the earliest start of chemotherapy or study treatment or adverse event worsened (increased in severity) on or after the earliest start of chemotherapy or study treatment. Deaths: From consent signature to study end.
Adverse Event Reporting Description Mortality: in all randomized patients. AEs: in the safety population (received chemotherapy and/or at least 1 dose of DCVAC/PCa or placebo). At each contact, open-ended and non-leading verbal questioning of the patient by the investigator was used to inquire about AEs. Causal relationship of the AE to DCVAC/PCa or placebo was assessed by investigators. Disease progression-related events (as evaluated by investigators) were excluded from serious AE reporting but were captured as non-serious AEs.
 
Arm/Group Title DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Hide Arm/Group Description Combination therapy with DCVAC/PCa and standard of care chemotherapy (docetaxel and prednisone) Combination therapy with placebo and standard of care chemotherapy (docetaxel and prednisone) as comparator
All-Cause Mortality
DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   518/787 (65.82%)      254/395 (64.30%)    
Hide Serious Adverse Events
DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   237/749 (31.64%)      150/379 (39.58%)    
Blood and lymphatic system disorders     
Agranulocytosis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Anaemia  1  9/749 (1.20%)  14 3/379 (0.79%)  3
Bicytopenia  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Febrile neutropenia  1  25/749 (3.34%)  27 29/379 (7.65%)  34
Leukopenia  1  2/749 (0.27%)  3 2/379 (0.53%)  2
Neutropenia  1  12/749 (1.60%)  12 5/379 (1.32%)  7
Pancytopenia  1  4/749 (0.53%)  4 0/379 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  0/749 (0.00%)  0 2/379 (0.53%)  2
Angina pectoris  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Aortic valve stenosis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Atrial fibrillation  1  7/749 (0.93%)  8 2/379 (0.53%)  2
Atrial flutter  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Atrial tachycardia  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Atrioventricular block  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Cardiac arrest  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Cardiac failure  1  2/749 (0.27%)  2 2/379 (0.53%)  2
Cardiac failure acute  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Cardiac failure congestive  1  1/749 (0.13%)  1 2/379 (0.53%)  2
Cardiac failure chronic  1  0/749 (0.00%)  0 2/379 (0.53%)  2
Cardiogenic shock  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Cardiomyopathy  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Coronary artery disease  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Myocardial infarction  1  3/749 (0.40%)  3 1/379 (0.26%)  1
Myocarditis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Tachycardia  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Ventricular extrasystoles  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Eye disorders     
Diplopia  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Retinal detachment  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Uveitis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Abdominal pain upper  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Colitis ischaemic  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Constipation  1  2/749 (0.27%)  2 1/379 (0.26%)  1
Diarrhoea  1  5/749 (0.67%)  5 5/379 (1.32%)  6
Dysphagia  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Enterocolitis haemorrhagic  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Gastric antral vascular ectasia  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Gastric haemorrhage  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Gastric ulcer  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Gastric ulcer haemorrhage  1  0/749 (0.00%)  0 2/379 (0.53%)  2
Gastric ulcer perforation  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Gastritis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Gastrointestinal haemorrhage  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Gastrointestinal inflammation  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Haematochezia  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Haemorrhoidal haemorrhage  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Ileus  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Intestinal obstruction  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Large intestine perforation  1  0/749 (0.00%)  0 2/379 (0.53%)  2
Nausea  1  1/749 (0.13%)  1 3/379 (0.79%)  4
Obstructive pancreatitis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Oesophagitis  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Pancreatitis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Pancreatitis acute  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Peptic ulcer  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Rectal haemorrhage  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Rectal perforation  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Small intestinal haemorrhage  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Small intestinal obstruction  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Small intestinal stenosis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Stomatitis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Vomiting  1  2/749 (0.27%)  2 4/379 (1.06%)  6
General disorders     
Asthenia  1  3/749 (0.40%)  3 1/379 (0.26%)  1
Catheter site inflammation  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Complication associated with device  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Death  1  5/749 (0.67%)  5 5/379 (1.32%)  5
Fatigue  1  5/749 (0.67%)  5 1/379 (0.26%)  1
General physical health deterioration  1  6/749 (0.80%)  6 0/379 (0.00%)  0
Chest pain  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Non-cardiac chest pain  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Oedema peripheral  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Pyrexia  1  9/749 (1.20%)  13 6/379 (1.58%)  9
Sudden death  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Systemic inflammatory response syndrome  1  0/749 (0.00%)  0 3/379 (0.79%)  4
Hepatobiliary disorders     
Hepatic cyst  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Hepatic failure  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Immune system disorders     
Allergy to arthropod sting  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Anaphylactic reaction  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Hypersensitivity  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Infections and infestations     
Abdominal infection  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Abscess limb  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Abscess oral  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Abscess soft tissue  1  1/749 (0.13%)  2 0/379 (0.00%)  0
Anal abscess  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Appendicitis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Biliary tract infection  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Bronchitis  1  2/749 (0.27%)  2 2/379 (0.53%)  2
Catheter site cellulitis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Cellulitis  1  3/749 (0.40%)  3 0/379 (0.00%)  0
Cellulitis orbital  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Clostridium difficile colitis  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Clostridium difficile infection  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Complicated appendicitis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Cytomegalovirus infection  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Cytomegalovirus oesophagitis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Dermo-hypodermitis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Device related infection  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Device related sepsis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Diverticulitis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Enterococcal bacteraemia  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Enterocolitis infectious  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Erysipelas  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Escherichia sepsis  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Gastroenteritis  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Gastroenteritis norovirus  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Gastroenteritis viral  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Herpes zoster  1  0/749 (0.00%)  0 2/379 (0.53%)  2
Cholangitis infective  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Infection  1  3/749 (0.40%)  3 1/379 (0.26%)  1
Influenza  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Lower respiratory tract infection  1  0/749 (0.00%)  0 2/379 (0.53%)  2
Neutropenic sepsis  1  7/749 (0.93%)  7 5/379 (1.32%)  7
Osteomyelitis  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Paraspinal abscess  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Perirectal abscess  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Peritonitis  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Pneumonia  1  18/749 (2.40%)  18 11/379 (2.90%)  13
Pneumonia mycoplasmal  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Pneumonia viral  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Pyelonephritis  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Rectal abscess  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Respiratory tract infection  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Sepsis  1  8/749 (1.07%)  8 5/379 (1.32%)  5
Septic shock  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Staphylococcal abscess  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Staphylococcal bacteraemia  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Staphylococcal sepsis  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Streptococcal sepsis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Tracheobronchitis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Urinary tract infection  1  10/749 (1.34%)  13 8/379 (2.11%)  9
Urinary tract infection staphylococcal  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Urosepsis  1  3/749 (0.40%)  3 0/379 (0.00%)  0
Viral sepsis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  0/749 (0.00%)  0 2/379 (0.53%)  2
Cystitis radiation  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Femoral neck fracture  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Fibula fracture  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Gastrointestinal stoma complication  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Hip fracture  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Jaw fracture  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Lower limb fracture  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Lumbar vertebral fracture  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Postoperative wound complication  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Radiation proctitis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Skull fracture  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Spinal compression fracture  1  0/749 (0.00%)  0 2/379 (0.53%)  2
Subdural haematoma  1  2/749 (0.27%)  2 1/379 (0.26%)  1
Subdural haemorrhage  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Investigations     
Blood creatinine increased  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Computerised tomogram abnormal  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Neutrophil count decreased  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Dehydration  1  6/749 (0.80%)  6 4/379 (1.06%)  4
Diabetes mellitus  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Diabetic metabolic decompensation  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Failure to thrive  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Hyperglycaemia  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Hypoglycaemia  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Hyponatraemia  1  4/749 (0.53%)  4 0/379 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Arthritis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Back pain  1  7/749 (0.93%)  7 1/379 (0.26%)  1
Bone pain  1  1/749 (0.13%)  1 2/379 (0.53%)  2
Bursitis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Musculoskeletal pain  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Neck pain  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Osteitis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Osteoarthritis  1  1/749 (0.13%)  1 2/379 (0.53%)  2
Osteonecrosis of jaw  1  5/749 (0.67%)  5 1/379 (0.26%)  1
Pain in extremity  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Pathological fracture  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Periarthritis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Spinal pain  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Anal squamous cell carcinoma  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Basal cell carcinoma  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Cancer pain  1  1/749 (0.13%)  1 3/379 (0.79%)  3
Carcinoid tumour  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Cardiac myxoma  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Chondrosarcoma  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Chronic lymphocytic leukaemia  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Malignant melanoma  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Malignant pleural effusion  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Nervous system disorders     
Amnesia  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Brain injury  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Cauda equina syndrome  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Cerebral haemorrhage  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Cerebral infarction  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Cerebral venous thrombosis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Cerebrovascular accident  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Diabetic coma  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Ischaemic cerebral infarction  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Ischaemic stroke  1  3/749 (0.40%)  3 2/379 (0.53%)  3
Loss of consciousness  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Monoparesis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Neuropathy peripheral  1  1/749 (0.13%)  1 2/379 (0.53%)  2
Paraparesis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Paraplegia  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Peripheral motor neuropathy  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Peripheral sensory neuropathy  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Polyneuropathy  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Sciatica  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Seizure  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Spinal cord compression  1  2/749 (0.27%)  2 1/379 (0.26%)  1
Superior sagittal sinus thrombosis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Syncope  1  7/749 (0.93%)  8 3/379 (0.79%)  3
Transient ischaemic attack  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Vertigo CNS origin  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Product Issues     
Device occlusion  1  1/749 (0.13%)  2 0/379 (0.00%)  0
Psychiatric disorders     
Mental status changes  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Nightmare  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  5/749 (0.67%)  5 4/379 (1.06%)  4
Calculus bladder  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Haematuria  1  6/749 (0.80%)  8 0/379 (0.00%)  0
Hydronephrosis  1  6/749 (0.80%)  6 2/379 (0.53%)  2
Chronic kidney disease  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Renal atrophy  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Renal failure  1  3/749 (0.40%)  3 1/379 (0.26%)  1
Renal impairment  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Ureterolithiasis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Urinary retention  1  7/749 (0.93%)  8 4/379 (1.06%)  5
Urinary tract obstruction  1  1/749 (0.13%)  1 1/379 (0.26%)  1
Reproductive system and breast disorders     
Pelvic pain  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Scrotal oedema  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Acute respiratory failure  1  4/749 (0.53%)  4 2/379 (0.53%)  2
Dyspnoea  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Dyspnoea exertional  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Hydrothorax  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Hypoxia  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Chronic obstructive pulmonary disease  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Interstitial lung disease  1  2/749 (0.27%)  3 3/379 (0.79%)  3
Pleural effusion  1  3/749 (0.40%)  3 0/379 (0.00%)  0
Pneumonia aspiration  1  2/749 (0.27%)  2 2/379 (0.53%)  2
Pneumonitis  1  3/749 (0.40%)  3 1/379 (0.26%)  1
Pulmonary embolism  1  18/749 (2.40%)  18 15/379 (3.96%)  15
Pulmonary fibrosis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Pulmonary oedema  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Respiratory failure  1  4/749 (0.53%)  4 0/379 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash erythematous  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Vascular disorders     
Aortic stenosis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Deep vein thrombosis  1  4/749 (0.53%)  5 1/379 (0.26%)  1
Hypertension  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Hypotension  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Hypovolaemic shock  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Shock  1  2/749 (0.27%)  2 0/379 (0.00%)  0
Temporal arteritis  1  1/749 (0.13%)  1 0/379 (0.00%)  0
Thrombophlebitis  1  0/749 (0.00%)  0 1/379 (0.26%)  1
Venous thrombosis limb  1  0/749 (0.00%)  0 1/379 (0.26%)  1
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DCVAC/PCa With Standard of Care Chemotherapy Placebo With Standard of Care Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   670/749 (89.45%)      365/379 (96.31%)    
Blood and lymphatic system disorders     
Anaemia  1  123/749 (16.42%)  159 76/379 (20.05%)  96
Leukopenia  1  63/749 (8.41%)  103 33/379 (8.71%)  74
Neutropenia  1  103/749 (13.75%)  177 54/379 (14.25%)  92
Eye disorders     
Lacrimation increased  1  29/749 (3.87%)  29 30/379 (7.92%)  32
Gastrointestinal disorders     
Abdominal pain  1  28/749 (3.74%)  31 23/379 (6.07%)  26
Constipation  1  111/749 (14.82%)  133 71/379 (18.73%)  94
Diarrhoea  1  204/749 (27.24%)  338 115/379 (30.34%)  183
Dyspepsia  1  44/749 (5.87%)  47 22/379 (5.80%)  26
Nausea  1  150/749 (20.03%)  196 96/379 (25.33%)  142
Stomatitis  1  39/749 (5.21%)  54 24/379 (6.33%)  35
Vomiting  1  78/749 (10.41%)  97 43/379 (11.35%)  53
General disorders     
Asthenia  1  106/749 (14.15%)  156 69/379 (18.21%)  107
Fatigue  1  268/749 (35.78%)  374 152/379 (40.11%)  219
Mucosal inflammation  1  28/749 (3.74%)  33 22/379 (5.80%)  37
Oedema peripheral  1  121/749 (16.15%)  146 87/379 (22.96%)  107
Pyrexia  1  76/749 (10.15%)  104 42/379 (11.08%)  64
Infections and infestations     
Nasopharyngitis  1  33/749 (4.41%)  39 22/379 (5.80%)  26
Upper respiratory tract infection  1  34/749 (4.54%)  41 20/379 (5.28%)  23
Urinary tract infection  1  53/749 (7.08%)  76 39/379 (10.29%)  66
Investigations     
Weight decreased  1  46/749 (6.14%)  48 24/379 (6.33%)  25
Metabolism and nutrition disorders     
Decreased appetite  1  110/749 (14.69%)  137 79/379 (20.84%)  102
Hyperglycaemia  1  56/749 (7.48%)  81 27/379 (7.12%)  41
Musculoskeletal and connective tissue disorders     
Arthralgia  1  114/749 (15.22%)  153 74/379 (19.53%)  110
Back pain  1  113/749 (15.09%)  135 67/379 (17.68%)  79
Bone pain  1  78/749 (10.41%)  91 26/379 (6.86%)  29
Muscular weakness  1  32/749 (4.27%)  36 23/379 (6.07%)  26
Musculoskeletal pain  1  46/749 (6.14%)  51 24/379 (6.33%)  28
Myalgia  1  53/749 (7.08%)  74 32/379 (8.44%)  47
Pain in extremity  1  87/749 (11.62%)  104 55/379 (14.51%)  74
Nervous system disorders     
Dizziness  1  41/749 (5.47%)  47 33/379 (8.71%)  40
Dysgeusia  1  80/749 (10.68%)  105 59/379 (15.57%)  91
Headache  1  35/749 (4.67%)  38 27/379 (7.12%)  33
Hypoaesthesia  1  32/749 (4.27%)  41 20/379 (5.28%)  25
Neuropathy peripheral  1  83/749 (11.08%)  110 54/379 (14.25%)  59
Paraesthesia  1  76/749 (10.15%)  95 33/379 (8.71%)  42
Peripheral sensory neuropathy  1  36/749 (4.81%)  39 28/379 (7.39%)  31
Polyneuropathy  1  44/749 (5.87%)  47 24/379 (6.33%)  28
Taste disorder  1  37/749 (4.94%)  39 21/379 (5.54%)  23
Psychiatric disorders     
Insomnia  1  32/749 (4.27%)  33 24/379 (6.33%)  25
Respiratory, thoracic and mediastinal disorders     
Cough  1  82/749 (10.95%)  95 47/379 (12.40%)  54
Dyspnoea  1  82/749 (10.95%)  103 55/379 (14.51%)  65
Skin and subcutaneous tissue disorders     
Alopecia  1  222/749 (29.64%)  224 130/379 (34.30%)  131
Nail disorder  1  38/749 (5.07%)  41 28/379 (7.39%)  28
Rash  1  36/749 (4.81%)  40 22/379 (5.80%)  25
Vascular disorders     
Hypertension  1  43/749 (5.74%)  56 34/379 (8.97%)  44
Hypotension  1  40/749 (5.34%)  48 28/379 (7.39%)  39
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any formal publication of clinical trial results will be a collaborative effort between the sponsor and the investigator(s). All manuscripts or abstracts will be reviewed and approved in written by the sponsor before submission. The sponsor may request a delay in publication if there are important intellectual property concerns but does not have the right to suppress the publication of the clinical trial results indefinitely.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Radek Spisek, M.D., Ph.D.
Organization: SOTIO a.s.
Phone: +420 2241 75101
EMail: spisek@sotio.com
Layout table for additonal information
Responsible Party: Sotio a.s.
ClinicalTrials.gov Identifier: NCT02111577    
Other Study ID Numbers: SP005
2012-002814-38 ( EudraCT Number )
First Submitted: April 9, 2014
First Posted: April 11, 2014
Results First Submitted: January 22, 2021
Results First Posted: April 6, 2021
Last Update Posted: April 6, 2021