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

NCT02458716 | Completed Phase 1

• 4 other identifiers: Pro20140001022NCI-2015-00384081403P30CA072720
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to PSA nadir

  Up to 3 years

• Time to rising PSA while on the standard androgen deprivation therapy

  Up to 3 years

Study Arms (1)

Surgery followed by hormone therapy (ADT)

EXPERIMENTAL

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.

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)

Interventions

Robotic Assisted Radical Prostatectomy PROCEDURE

Undergo RARP

Surgery followed by hormone therapy (ADT)

Conventional open retropubic radical prostectomy PROCEDURE

Undergo conventional open RRP

Surgery followed by hormone therapy (ADT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Surgery followed by hormone therapy (ADT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Surgery followed by hormone therapy (ADT)

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)

Also known as: Hormone therapy

Surgery followed by hormone therapy (ADT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (3)

City of Hope National Medical Center (COH)

Duarte, California, 91010, United States

Location

University of California, Irvine (UCI)

Orange, California, 92868, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Isaac Kim

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: June 1, 2015
• Study Start: March 6, 2015
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (3)