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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center (COH)
    • Orange, California, United States, 92868
      • University of California, Irvine (UCI)
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Surgery followed by hormone therapy (ADT); 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.

Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Robotic Assisted Radical Prostatectomy; Undergo RARP; Procedure: Conventional open retropubic radical prostectomy; Undergo conventional open RRP; Drug: ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide); LHRH agonist or antagonist (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide); Other Names: Hormone therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher	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.	Within 90 days after cytoreductive prostatectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to PSA nadir	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.	Up to 3 years
Time to rising PSA while on the standard androgen deprivation therapy	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.	Up to 3 years

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Rutgers Cancer Institute of New Jersey
• Investigators: Principal Investigator: Isaac Kim, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2015
• Primary Completion (Actual): January 14, 2020
• Study Completion (Actual): January 14, 2020

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (Estimate): June 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Carcinoma; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Androgen Antagonists; Leuprolide; Bicalutamide; Androgens; Androgen Receptor Antagonists
• Other Study ID Numbers: Pro20140001022 (Other Identifier: IRB Number); P30CA072720 (U.S. NIH Grant/Contract); NCI-2015-00384 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 081403 (Other Identifier: Rutgers Cancer Institute of New Jersey)