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

Completed · Phase 1

Conditions studied: Metastatic Prostate Carcinoma, Metastatic Prostatic Adenocarcinoma, Prostate Carcinoma Metastatic to the Bone

In brief

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.

Key facts

Study ID

NCT02458716

Run by

Rutgers, The State University of New Jersey

People needed

26

Starts

2015-03-06

Expected to finish

2020-01-14

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope National Medical Center (COH) — Duarte, California, United States
• University of California, Irvine (UCI) — Orange, California, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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