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

Phase 1

Completed

• Conditions: Metastatic Prostatic Adenocarcinoma; Metastatic Prostate Carcinoma; Prostate Carcinoma Metastatic to the Bone
• Interventions: Procedure: Robotic Assisted Radical Prostatectomy; Procedure: Conventional open retropubic radical prostectomy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)

• Registration Number: NCT02458716
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-03-06
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-01
• Primary Completion: 2020-01-14
• Study Completion: 2020-01-14
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery followed by hormone therapy (ADT)	Robotic Assisted Radical Prostatectomy	Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.
Surgery followed by hormone therapy (ADT)	Laboratory Biomarker Analysis	Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.
Surgery followed by hormone therapy (ADT)	Quality-of-Life Assessment	Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.
Surgery followed by hormone therapy (ADT)	ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)	Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.
Surgery followed by hormone therapy (ADT)	Conventional open retropubic radical prostectomy	Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.

Primary Outcome Measures

Name	Time	Method
Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher	Within 90 days after cytoreductive prostatectomy	Rate will be calculated for the primary end point, and one-sided Binomial test will be used to compare the rate to the hypothesized value. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.

Secondary Outcome Measures

Name	Time	Method
Time to rising PSA while on the standard androgen deprivation therapy	Up to 3 years	Time to event data will be analyzed using the Kaplan-Meier product limit method. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.
Time to PSA nadir	Up to 3 years	Time to event data will be analyzed using the Kaplan-Meier product limit method. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.

Trial Locations

Locations (3)

City of Hope National Medical Center (COH); 🇺🇸 Duarte, California, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

University of California, Irvine (UCI); 🇺🇸 Orange, California, United States