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

April 7, 2021 updated by: Isaac Yi Kim, MD, PhD, MBA, Rutgers, The State University of New Jersey

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 90 days after cytoreductive prostatectomy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 3 years
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.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isaac Kim, Rutgers Cancer Institute of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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