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NCT Number: NCT02458716

Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, 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.

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Key information

Conditions

Metastatic Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Prostatic Adenocarcinoma Neoplasms Neoplasms by Site Prostate Carcinoma Metastatic to the Bone Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

robotic assisted radical prostatectomy

Procedure

Undergo RARP

Conventional open retropubic radical prostectomy

Procedure

Undergo conventional open RRP

laboratory biomarker analysis

Other

Correlative studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

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

Drug

LHRH agonist or antagonist (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)

Other names: Hormone therapy

Primary outcomes

  1. Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher

    Time frame: 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 outcomes

  1. Time to PSA nadir

    Time frame: 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.

  2. Time to rising PSA while on the standard androgen deprivation therapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2015
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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