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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Robotic Assisted Radical Prostatectomy
Conventional open retropubic radical prostectomy
Laboratory Biomarker Analysis
Quality-of-Life Assessment
ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • City of Hope National Medical Center (COH)
  • University of California, Irvine (UCI)
  • Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery followed by hormone therapy (ADT)

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 6, 2015
Last Updated
April 7, 2021
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT02458716
Brief Title
Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer
Official Title
Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed With Metastatic Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 6, 2015 (Actual)
Primary Completion Date
January 14, 2020 (Actual)
Study Completion Date
January 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Carcinoma, Metastatic Prostatic Adenocarcinoma, Prostate Carcinoma Metastatic to the Bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery followed by hormone therapy (ADT)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Robotic Assisted Radical Prostatectomy
Intervention Description
Undergo RARP
Intervention Type
Procedure
Intervention Name(s)
Conventional open retropubic radical prostectomy
Intervention Description
Undergo conventional open RRP
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
Other Intervention Name(s)
Hormone therapy
Intervention Description
LHRH agonist or antagonist (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
Primary Outcome Measure Information:
Title
Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher
Description
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.
Time Frame
Within 90 days after cytoreductive prostatectomy
Secondary Outcome Measure Information:
Title
Time to PSA nadir
Description
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.
Time Frame
Up to 3 years
Title
Time to rising PSA while on the standard androgen deprivation therapy
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaac Kim
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope National Medical Center (COH)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, Irvine (UCI)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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

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