Summary

for males ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

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.

Official Title

Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed With Metastatic Prostate Cancer

Details

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Keywords

Metastatic Prostate CarcinomaMetastatic Prostatic AdenocarcinomaProstate Carcinoma Metastatic to the BoneCarcinomaProstatic NeoplasmsAdenocarcinomaHormonesAndrogensLeuprolideBicalutamideAndrogen Receptor AntagonistsRobotic Assisted Radical ProstatectomyConventional open retropubic radical prostectomyLaboratory Biomarker AnalysisQuality-of-Life AssessmentADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)Surgery followed by hormone therapy (ADT)

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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 CAN'T join 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

Locations

  • University of California, Irvine (UCI)
    OrangeCalifornia92868United States
  • City of Hope National Medical Center (COH)
    DuarteCalifornia91010United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rutgers, The State University of New Jersey
ID
NCT02458716
Phase
Phase 1
Study Type
Interventional
Last Updated