Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed with Metastatic Prostate Cancer
Phase 1
- Conditions
- metastatic prostate cancer
- Registration Number
- JPRN-UMIN000021303
- Lead Sponsor
- Juntendo University, Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1 Males under the age of 20. 2 Refuses to give informed consent. 3 Refuses or is unable to have pelvic MRI or CT scan. 4 Clinical stage T4 (pelvic MRI shows rectal and/or ureteral invasion). 5 Deemed a poor surgical risk per primary medical doctor. 6 Known spinal cord compression or brain or liver metastasis or any other visceral metastases. 7 DVT/PE in the past 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the rate of major peri-operative complications (Clavien-Dindo grade III or higher, please see appendix A) that occur within 90 days after cytoreductive prostatectomy.
- Secondary Outcome Measures
Name Time Method 1) time to PSA nadir and 2) time to rising PSA while on standard systemic therapy.