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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot] Drug: 2-Hydroxyflutamide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open, Single and Multiple Dose, Efficacy and Safety Proof of Principle Study of Liproca Depot, a Controlled Release Formulation of 2-hydroxyflutamide, Injected Into the Prostate in Patients With Localized Prostate Cancer|
|Study Start Date :||June 2009|
|Primary Completion Date :||May 2011|
|Study Completion Date :||July 2011|
Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe
Drug: 2-hydroxyflutamide (2-HOF) [Liproca Depot]
Ready made paste including 600 mg 2-HOF for injection as a single dose
Other Name: Liproca DepotDrug: 2-Hydroxyflutamide
The Product consists of two sterile components, one aqueous liquid and a dry powder, containing the active drug 2-Hydroxyflutamide (2-HOF. The two components were mixed under aceptic conditions to a paste prior to administration.
Other Name: Liproca Depot
- Proportion of Patients Showing PSA Nadir [ Time Frame: Measured every 4th week until progression or maximum 6 months. ]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.
- Number of Patients Reporting Adverse Events Caused by the Study Treatment [ Time Frame: Measured every 4th week till progression or maximum 6 months ]
- Adverse events caused by the study treatment
- Abnormal, clinically relevant, laboratory parameters
- Voiding symptoms
- Vital Signs
- Quality of Life
- Percent Change in Prostate Volume From Baseline to Nadir. [ Time Frame: Measured every 4th week until progression or maximum 6 months. ]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 to PSA Nadir [ Time Frame: Measured every 4th week until progression or maximum 6 moths. ]Time frame was from baseline to day of PSA nadir.
- Percent Change in Prostate Volume From Baseline to Final Visit [ Time Frame: Measured every 4th week until progresion or maximum 6 months. ]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
- Number of Days to Prostate Volume Nadir. [ Time Frame: Measured every 4th week until progression or maximum 6 months. ]Number of Days from day of injection to prostate volume nadir.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913263
|Tampere University Hospital|
|Tampere, Finland, 33520|
|Tampere University Hospital|
|Principal Investigator:||Teuvo Tammela, Professor||Tampere University Hospital|