Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
- Conditions
- Neoplasms, Prostate
- Interventions
- Registration Number
- NCT00470834
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 127
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 dutasteride 50 mg bicalutamide and 3.5 mg Dutasteride (IP) Arm 1 bicalutamide 50 mg bicalutamide and 3.5 mg Dutasteride (IP) Arm 2 placebo 50 mg bicalutamide and placebo Arm 2 bicalutamide 50 mg bicalutamide and placebo
- Primary Outcome Measures
Name Time Method Time to Disease Progression Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42) Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter \[ng/mL\] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.
- Secondary Outcome Measures
Name Time Method Time to Treatment Failure Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42) Time to treatment failure is defined as the interval of time between the date of the start of treatment and the date of treatment failure. Treatment failure is defined as PSA progression from Baseline (PSA value is 25% and at least 2 ng/mL above Baseline, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or receipt of post-baseline rescue medications. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.
Number of Participants With PSA Response Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42) PSA response is defined as a 50% or greater decrease in PSA from Baseline, confirmed by a second PSA measurement. The time of this response was the date of the first PSA measurement that showed a 50% or greater decrease from the Baseline PSA measurement. PSA confirmation was not required if no subsequent PSA values were available.
Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42 Baseline and Months 6, 12, 18, 21, and 42 Change from Baseline in total PSA was measured at each scheduled post-baseline visit using a general linear model with effects for treatment and Baseline total PSA. Analysis was done using the last observation carried forward (LOCF) approach, in which missing post-Baseline values were imputed with earlier non-missing values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Number of Participants With Metastatic Disease Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42) Metastatic disease is that evidenced by a radiographic assessment. The time of metastatic disease was the date of radiographic evidence.
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇦Quebec, Canada