SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 multi-institution randomized prospective clinical trial evaluating the impact of cytoreductive radical prostatectomy combined with best systemic therapy on oncologic and quality of life outcomes in men with newly diagnosed metastatic prostate cancer
Phase 2
Recruiting
- Conditions
- metastatic prostate cancer
- Registration Number
- JPRN-UMIN000036012
- Lead Sponsor
- Rutgers Cancer Institute of New Jersey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 190
Inclusion Criteria
Not provided
Exclusion Criteria
1Males under the age of 18. 2 Refuses to give informed consent. 3Deemed to have unresectable disease by surgeon. 4Received ADT for more than 6 months prior to randomization. 5Life expectancy of less than 6 months. 6 Known spinal cord compression. 7M1c disease (solid organ metastasis). 8 DVT/PE in the past 6 months. 9Previous local therapy for prostate cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint for the Phase 2 portion of this study is the failure-free survival (FFS) rate at two years after randomization. Failure is defined as: biochemical recurrence, clinical progression, or death from prostate cancer.
- Secondary Outcome Measures
Name Time Method There are seven secondary endpoints: 1) % PSA nadir < 0.2 ng/ml at six months after randomization, 2) overall complication rate, 3) time to biochemical progression, 4) time to clinical progression, 5) FFS (primary endpoint for phase 2 portion), 6) cancer-specific survival, and 7) overall survival (primary endpoint for phase 3 portion). Overall survival will switch to the primary endpoint if the study converts successfully to phase 3 trial.