A Randomized Double-Blind Parallel Group Study Comparing Casodex (or Generic Equivalent) 50mg Plus Placebo to Casodex (or Generic Equivalent) 50mg Plus Dutasteride 3.5mg Administered for 18 Months to Men With Prostate Cancer Who Have Failed First-Line Androgen Deprivation Therapy (Assessed by Rising PSA) Followed by a Two-Year Extension Phase
Overview
- Phase
- Phase 4
- Intervention
- bicalutamide
- Conditions
- Neoplasms, Prostate
- Sponsor
- GlaxoSmithKline
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- Time to Disease Progression
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1
50 mg bicalutamide and 3.5 mg Dutasteride (IP)
Intervention: bicalutamide
Arm 1
50 mg bicalutamide and 3.5 mg Dutasteride (IP)
Intervention: dutasteride
Arm 2
50 mg bicalutamide and placebo
Intervention: placebo
Arm 2
50 mg bicalutamide and placebo
Intervention: bicalutamide
Outcomes
Primary Outcomes
Time to Disease Progression
Time Frame: 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 Outcomes
- 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))
- 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))
- Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42(Baseline and Months 6, 12, 18, 21, and 42)
- 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))