Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 1438 for:    prostate cancer AND radiation

Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM) (STREAM)

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: NCT02057939
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : March 20, 2019
Last Update Posted : June 26, 2019
Sponsor:
Collaborators:
Medivation, Inc.
Astellas Pharma Inc
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: enzalutamide
Drug: Androgen Deprivation
Radiation: Radiation Therapy
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enzalutamide
Hide Arm/Group Description

Enzalutamide, Androgen Deprivation, and Radiation Therapy

enzalutamide: 160 mg orally once daily for six months

Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Period Title: Overall Study
Started 38
Completed 37
Not Completed 1
Arm/Group Title Enzalutamide
Hide Arm/Group Description

Enzalutamide, Androgen Deprivation, and Radiation Therapy

enzalutamide: 160 mg orally once daily for six months

Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 38 participants
64
(39 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
0
   0.0%
Male
38
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
38
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   7.9%
White
34
  89.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Two Year Progression-free Survival
Hide Description Percentage of patients surviving 2 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:

Enzalutamide, Androgen Deprivation, and Radiation Therapy

enzalutamide: 160 mg orally once daily for six months

Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
64.9
(47.3 to 77.9)
2.Secondary Outcome
Title PSA Less Than 0.1
Hide Description The percentage of men with PSA less than 0.1 ng/mL and testosterone greater than 100
Time Frame every year, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses. Note that 11 patients did not have PSA measurements at 2 years and 24 did not have PSA measurements at 3 years. They are still included in the denominator.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:

Enzalutamide, Androgen Deprivation, and Radiation Therapy

enzalutamide: 160 mg orally once daily for six months

Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage
1 year 75.7
2 year 48.6
3 year 32.4
3.Secondary Outcome
Title Three Year Progression-free Survival
Hide Description Percentage of patients surviving 3 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:

Enzalutamide, Androgen Deprivation, and Radiation Therapy

enzalutamide: 160 mg orally once daily for six months

Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
53.2
(35.9 to 67.9)
4.Secondary Outcome
Title Biochemical Progression-free Survival
Hide Description Percentage of patients surviving 2 and 3 years from the start of study treatment without progression of disease. Biochemical PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:

Enzalutamide, Androgen Deprivation, and Radiation Therapy

enzalutamide: 160 mg orally once daily for six months

Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
2 year bPFS
64.9
(47.3 to 77.9)
3 year bPFS
53.2
(35.9 to 67.9)
5.Secondary Outcome
Title PSA Nadir
Hide Description Median PSA nadir post-radiation therapy
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:

Enzalutamide, Androgen Deprivation, and Radiation Therapy

enzalutamide: 160 mg orally once daily for six months

Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Overall Number of Participants Analyzed 37
Median (Full Range)
Unit of Measure: ng/ml
0
(0 to 0.1)
6.Secondary Outcome
Title Time to Testosterone Recovery
Hide Description Percentage of patients with recovering testosterone to > 100 at 1, 2, and 3 years.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.
Arm/Group Title Enzalutamide
Hide Arm/Group Description:

Enzalutamide, Androgen Deprivation, and Radiation Therapy

enzalutamide: 160 mg orally once daily for six months

Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage
1 year 94.6
2 year 100
3 year 100
7.Secondary Outcome
Title Number of Patients With Adverse Events Related to Combination Enzalutamide, ADT, and XRT
Hide Description Safety and tolerability will be assessed using CTCAE v4.0
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enzalutamide
Hide Arm/Group Description:

Enzalutamide, Androgen Deprivation, and Radiation Therapy

enzalutamide: 160 mg orally once daily for six months

Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: participants
36
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enzalutamide
Hide Arm/Group Description

Enzalutamide, Androgen Deprivation, and Radiation Therapy

enzalutamide: 160 mg orally once daily for six months

Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.

Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy

All-Cause Mortality
Enzalutamide
Affected / at Risk (%)
Total   0/38 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Enzalutamide
Affected / at Risk (%)
Total   2/38 (5.26%) 
Cardiac disorders   
Myocardial infarction  1  1/38 (2.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Other, Specify: BLADDER  1  1/38 (2.63%) 
Renal and urinary disorders   
Urinary retention  1  1/38 (2.63%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enzalutamide
Affected / at Risk (%)
Total   38/38 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  9/38 (23.68%) 
Cardiac disorders   
Acute coronary syndrome  1  1/38 (2.63%) 
Atrial fibrillation  1  1/38 (2.63%) 
Ear and labyrinth disorders   
Other, Specify: EAR PRESSURE  1  1/38 (2.63%) 
Tinnitus  1  1/38 (2.63%) 
Vertigo  1  1/38 (2.63%) 
Eye disorders   
Blurred vision  1  1/38 (2.63%) 
Other, Specify: FLOATERS  1  1/38 (2.63%) 
Other, Specify: PSUEDOPHAKIA  1  1/38 (2.63%) 
Gastrointestinal disorders   
Abdominal pain  1  1/38 (2.63%) 
Constipation  1  7/38 (18.42%) 
Diarrhea  1  13/38 (34.21%) 
Dyspepsia  1  2/38 (5.26%) 
Flatulence  1  1/38 (2.63%) 
Hemorrhoids  1  1/38 (2.63%) 
Nausea  1  6/38 (15.79%) 
Rectal hemorrhage  1  1/38 (2.63%) 
Vomiting  1  1/38 (2.63%) 
General disorders   
Edema limbs  1  1/38 (2.63%) 
Fatigue  1  30/38 (78.95%) 
Fever  1  1/38 (2.63%) 
Gait disturbance  1  1/38 (2.63%) 
Injection site reaction  1  1/38 (2.63%) 
Irritability  1  1/38 (2.63%) 
Malaise  1  1/38 (2.63%) 
Non-cardiac chest pain  1  1/38 (2.63%) 
Pain  1  6/38 (15.79%) 
Infections and infestations   
Bronchial infection  1  1/38 (2.63%) 
Other, Specify: COMMON COLD  1  1/38 (2.63%) 
Other, Specify: TICK BITE WITH FEVER, CHILLS, BODY ACHES, HEADACHES  1  1/38 (2.63%) 
Papulopustular rash  1  1/38 (2.63%) 
Skin infection  1  3/38 (7.89%) 
Injury, poisoning and procedural complications   
Fall  1  1/38 (2.63%) 
Investigations   
Alanine aminotransferase increased  1  3/38 (7.89%) 
Aspartate aminotransferase increased  1  1/38 (2.63%) 
Blood bilirubin increased  1  2/38 (5.26%) 
Cardiac troponin I increased  1  1/38 (2.63%) 
Lymphocyte count decreased  1  7/38 (18.42%) 
Platelet count decreased  1  1/38 (2.63%) 
Weight gain  1  2/38 (5.26%) 
Weight loss  1  2/38 (5.26%) 
White blood cell decreased  1  6/38 (15.79%) 
Metabolism and nutrition disorders   
Anorexia  1  2/38 (5.26%) 
Hyperglycemia  1  5/38 (13.16%) 
Hyperkalemia  1  1/38 (2.63%) 
Hypernatremia  1  1/38 (2.63%) 
Hypoalbuminemia  1  1/38 (2.63%) 
Hypoglycemia  1  1/38 (2.63%) 
Hypokalemia  1  1/38 (2.63%) 
Hypomagnesemia  1  1/38 (2.63%) 
Hyponatremia  1  3/38 (7.89%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/38 (7.89%) 
Arthritis  1  1/38 (2.63%) 
Back pain  1  4/38 (10.53%) 
Bone pain  1  1/38 (2.63%) 
Chest wall pain  1  1/38 (2.63%) 
Generalized muscle weakness  1  1/38 (2.63%) 
Other, Specify  1  1/38 (2.63%) 
Neck pain  1  1/38 (2.63%) 
Pain in extremity  1  5/38 (13.16%) 
Nervous system disorders   
Akathisia  1  1/38 (2.63%) 
Dizziness  1  3/38 (7.89%) 
Dysesthesia  1  1/38 (2.63%) 
Dysgeusia  1  7/38 (18.42%) 
Headache  1  7/38 (18.42%) 
Memory impairment  1  5/38 (13.16%) 
Movements involuntary  1  1/38 (2.63%) 
Other, Specify: RESTLESS LEG SYNDROME  1  1/38 (2.63%) 
Other, Specify: RESTLESS LEGS  1  5/38 (13.16%) 
Other, Specify: RESTLESS LEGS; INTERMITTENT/AT NIGHT  1  1/38 (2.63%) 
Other, Specify: VIVID DREAMS  1  2/38 (5.26%) 
Paresthesia  1  2/38 (5.26%) 
Peripheral motor neuropathy  1  1/38 (2.63%) 
Tremor  1  1/38 (2.63%) 
Vasovagal reaction  1  1/38 (2.63%) 
Psychiatric disorders   
Anxiety  1  4/38 (10.53%) 
Depression  1  2/38 (5.26%) 
Insomnia  1  15/38 (39.47%) 
Libido decreased  1  3/38 (7.89%) 
Personality change  1  2/38 (5.26%) 
Renal and urinary disorders   
Cystitis noninfective  1  1/38 (2.63%) 
Hematuria  1  1/38 (2.63%) 
Other, Specify: NOCTURIA  1  2/38 (5.26%) 
Other, Specify: NOCTURIA, RELATED TO RADIATION  1  1/38 (2.63%) 
Urinary frequency  1  11/38 (28.95%) 
Urinary incontinence  1  1/38 (2.63%) 
Urinary retention  1  4/38 (10.53%) 
Urinary tract pain  1  1/38 (2.63%) 
Urinary urgency  1  5/38 (13.16%) 
Reproductive system and breast disorders   
Breast pain  1  1/38 (2.63%) 
Gynecomastia  1  2/38 (5.26%) 
Testicular pain  1  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/38 (2.63%) 
Cough  1  4/38 (10.53%) 
Dyspnea  1  4/38 (10.53%) 
Nasal congestion  1  3/38 (7.89%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  5/38 (13.16%) 
Pruritus  1  3/38 (7.89%) 
Rash acneiform  1  1/38 (2.63%) 
Rash maculo-papular  1  2/38 (5.26%) 
Other, Specify: A LUMP JUST ABOVE ANTECUBITAL SPACE OF LEFT ARM  1  1/38 (2.63%) 
Other, Specify: ABRASION WITH EDEMA, LEFT ANKLE, DUE TO TRAUMA TO LEFT LEG  1  1/38 (2.63%) 
Other, Specify: ECZEMA BILATERAL ELBOWS AND LEFT SHIN  1  1/38 (2.63%) 
Other, Specify: ONE SPOT ON EACH ARM  1  1/38 (2.63%) 
Other, Specify: SKIN IRRITATION  1  1/38 (2.63%) 
Skin ulceration  1  2/38 (5.26%) 
Surgical and medical procedures   
Other, Specify: MOHS SURGERY FOR BASAL CELL  1  1/38 (2.63%) 
Other, Specify: RECTAL IRRITATION, RELATED TO RADIATION  1  1/38 (2.63%) 
Vascular disorders   
Hot flashes  1  28/38 (73.68%) 
Hypertension  1  7/38 (18.42%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Armstrong, MD ScM
Organization: Duke University
Phone: 919-668-4615
EMail: andrew.armstrong@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02057939     History of Changes
Other Study ID Numbers: Pro00049865
First Submitted: January 31, 2014
First Posted: February 7, 2014
Results First Submitted: February 27, 2019
Results First Posted: March 20, 2019
Last Update Posted: June 26, 2019