metastatic prostate cancer
Conditions
Interventions
Patients deemed to have cT3 or less will be offered the Robotic Assisted Radical Prostatectomy (RARP).
Sponsors
Juntendo University, Graduate School of Medicine
Rutgers Cancer Institute of New Jersey, University of Pennsylvania (Philadelphia, PA), Temple University (Philadelphia, PA), City of Hope (Duarte, CA), University of California at Irvine (Orange, CA), Swedish Medical Center (Seattle, WA), Seoul National University Bundang Hospital (Seoul, Korea)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1 Histologically proven adenocarcinoma of the prostate. 2 Evidence of lymph node or bone metastasis by MRI/CT, bone scan, or biopsy (N1Mx or NxM1). 3 Give informed consent. 4 Clinical stage T3 or less (pelvic MRI or CT scan shows no rectal and ureteral invasion). 5 Must be male and 18 years or older 6 Cleared by the primary medical doctor for surgery. 7 ECOG Performance Status of 0 or 1.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1) time to PSA nadir and 2) time to rising PSA while on standard systemic therapy. | — |
Countries
Japan,Asia(except Japan),North America
Contacts
Public ContactMasayoshi Nagata
Juntendo University Hospital Dept. of Urology
Outcome results
None listed