Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2020-01-14
• Target enrollment: 0
• Participant gender: Male

Summary

This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. When combined with hormone therapy, robotic assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy (RRP) may prolong survival in patients with prostate cancer that has spread.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Rutgers Cancer Institute of New Jersey
• Treatments: Androgen Receptor Antagonists; Androgens; Bicalutamide; Hormones; Leuprolide

Criteria

Inclusion Criteria:

• Histologically proven adenocarcinoma of the prostate

• Evidence of lymph node or bone metastasis by magnetic resonance imaging (MRI)/computed tomography (CT), bone scan, or biopsy (N1Mx or NxM1)

• Give informed consent

• Clinical stage T3 or less (pelvic MRI shows no rectal and ureteral invasion)

• Cleared by the primary medical doctor for surgery

• No prior systemic therapy for metastatic prostate cancer

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Refuses to give informed consent

• Refuses or is unable to have pelvic MRI

• Clinical stage T4 (pelvic MRI shows rectal and/or ureteral invasion)

• Deemed a poor surgical risk per primary medical doctor

• Received prior therapeutic intervention for metastatic prostate cancer

• Known spinal cord compression or brain or liver metastasis

• Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months