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Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed With Metastatic Prostate Cancer
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.
PRIMARY OBJECTIVES: I. To determine the safety and feasibility of cytoreductive prostatectomy (to remove as much of the primary cancer as possible) in men with newly diagnosed clinical T1-3N1M0 or T1-3N0M1a-b prostate cancer (herein, collectively referred to as metastatic prostate cancer). SECONDARY OBJECTIVES: I. Time to prostate specific antigen (PSA) nadir and castration resistance following cytoreductive prostatectomy and subsequent standard systemic therapy, androgen deprivation. OUTLINE: Patients undergo RARP or conventional open RRP. Immediately following surgery, patients receive standard systemic androgen deprivation therapy. After completion of study treatment, patients are followed up every 90 days for 3 years.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
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
Start Date
March 6, 2015
Primary Completion Date
January 14, 2020
Completion Date
January 14, 2020
Last Updated
April 8, 2021
26
ACTUAL participants
Robotic Assisted Radical Prostatectomy
PROCEDURE
Conventional open retropubic radical prostectomy
PROCEDURE
Laboratory Biomarker Analysis
OTHER
Quality-of-Life Assessment
OTHER
ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
DRUG
Lead Sponsor
Rutgers, The State University of New Jersey
Collaborators
NCT04550494
NCT06305598
Data Source & Attribution
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