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An Efficacy and Safety Study With Licroca Depot, a Controlled Release Product, Injected Into the Prostate (2-HOF)

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ClinicalTrials.gov Identifier: NCT00913263
Recruitment Status : Completed
First Posted : June 4, 2009
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Lidds AB

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot]
Drug: 2-Hydroxyflutamide
Enrollment 24
Recruitment Details Patients were recruited from the pool of patients with prostate cancer (T1-T2) available at the clinic. They were informed about the study by the Investigator
Pre-assignment Details There was only one Group assignment for the study. The patients (men with histologically confirmed localized prostate cancer, verifyed by biopsy), aged ≥ 45 years, with PSA value <20ng/mL, within 6 weeks before enrollment, and and Gleason score <3+4 at diagnostic biopsy.
Arm/Group Title Hydroxyflutamide (2-HOF)
Hide Arm/Group Description Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Group 1
Hide Arm/Group Description Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
24
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
68  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
0
   0.0%
Male
24
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Finland Number Analyzed 24 participants
24
1.Primary Outcome
Title Proportion of Patients Showing PSA Nadir
Hide Description Plasma PSA nadir is the lowest PSA reading achieved after any treatment for prostate cancer. The patients were observed once every 4th week during the study period.
Time Frame Measured every 4th week until progression or maximum 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description

All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, were included in the efficacy analysis.

Study population safety All patients who received at least one dose of Liproca® Depot were included in the safety analysis.

Arm/Group Title Part I
Hide Arm/Group Description:
Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
Overall Number of Participants Analyzed 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients with PSA nadir
83
(63 to 95)
2.Secondary Outcome
Title Number of Patients Reporting Adverse Events Caused by the Study Treatment
Hide Description
  • Adverse events caused by the study treatment
  • Abnormal, clinically relevant, laboratory parameters
  • Voiding symptoms
  • Vital Signs
  • Quality of Life
Time Frame Measured every 4th week till progression or maximum 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, should be included in the efficacy analysis.

Study population safety All patients who received at least one dose of Liproca® Depot should be included in the safety analysis.

Arm/Group Title Group 1
Hide Arm/Group Description:
24 patients (Part I of the study) have been injected with Liproca Depot once.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Patients reporting study related AE
12
3.Secondary Outcome
Title Percent Change in Prostate Volume From Baseline to Nadir.
Hide Description Prostate volume was measured at each visit to capture nadir and compared to baseline for all patients. Decrease in prostate volume is reported as percent change from baseline.
Time Frame Measured every 4th week until progression or maximum 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part I
Hide Arm/Group Description:
Patients (24 patients) in Part I have been injected with Liproca Depot once.
Overall Number of Participants Analyzed 24
Median (Standard Deviation)
Unit of Measure: percent change
14  (9.6)
4.Secondary Outcome
Title Time to PSA Nadir
Hide Description Time frame was from baseline to day of PSA nadir.
Time Frame Measured every 4th week until progression or maximum 6 moths.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part I
Hide Arm/Group Description:
Patients () 24 patients) in Part I have been injected with Liproca Depot once.
Overall Number of Participants Analyzed 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Number of days from baseline to PSA nadi
77
(32 to 126)
5.Secondary Outcome
Title Percent Change in Prostate Volume From Baseline to Final Visit
Hide Description Prostate volume was captured at each visit and percent change from baseline to final visit was measured. Final visit was either day of progression or after 6 months. Prostate volume decrease is reported in percent change from baseline
Time Frame Measured every 4th week until progresion or maximum 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part I
Hide Arm/Group Description:
Patients () 24 patients) in Part I have been injected with Liproca Depot once.
Overall Number of Participants Analyzed 24
Median (Standard Deviation)
Unit of Measure: percentage change
7  (11)
6.Secondary Outcome
Title Number of Days to Prostate Volume Nadir.
Hide Description Number of Days from day of injection to prostate volume nadir.
Time Frame Measured every 4th week until progression or maximum 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1
Hide Arm/Group Description:
Patients (24 patients) have been injected with Liproca depot once
Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: Days
112
(21 to 184)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Group 1
Affected / at Risk (%) # Events
Total   1/24 (4.17%)    
Infections and infestations   
Prostate infection * [1]  1/24 (4.17%)  1
*
Indicates events were collected by non-systematic assessment
[1]
The event was caused by the injectiontechnique
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Group 1
Affected / at Risk (%) # Events
Total   12/24 (50.00%)    
Renal and urinary disorders   
dysuria, haematuria   12/24 (50.00%)  16
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Teuvo Tammela, Professor
Organization: Dept. of Surgery, Tampere University Hospital, Tampere, Finland
Phone: +358-3-31164621
EMail: teuvo.tammela@uta.fi
Layout table for additonal information
Responsible Party: Lidds AB
ClinicalTrials.gov Identifier: NCT00913263    
Other Study ID Numbers: LPC-002
2009-010079-25 ( EudraCT Number )
First Submitted: June 3, 2009
First Posted: June 4, 2009
Results First Submitted: April 22, 2013
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015