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

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 1

Conditions: Prostate Carcinoma Metastatic to the Bone; Metastatic Prostatic Adenocarcinoma; Metastatic Prostate Carcinoma

Treatments: Drug: ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide); Procedure: Conventional open retropubic radical prostectomy; Other: Quality-of-Life Assessment; Procedure: Robotic Assisted Radical Prostatectomy; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02458716

P30CA072720 (U.S. NIH Grant/Contract)

Pro20140001022 (Other Identifier)

081403 (Other Identifier)

NCI-2015-00384 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Surgery followed by hormone therapy (ADT)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Procedure: Conventional open retropubic radical prostectomy

Other: Laboratory Biomarker Analysis

Drug: ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)

Procedure: Robotic Assisted Radical Prostatectomy