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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02458716
Recruitment Status : Active, not recruiting
First Posted : June 1, 2015
Last Update Posted : April 22, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Isaac Yi Kim, MD, PhD, MBA, Rutgers Cancer Institute of New Jersey

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.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Carcinoma Metastatic Prostatic Adenocarcinoma Prostate Carcinoma Metastatic to the Bone 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) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed With Metastatic Prostate Cancer
Actual Study Start Date : March 6, 2015
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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.
Procedure: Robotic Assisted Radical Prostatectomy
Undergo RARP

Procedure: Conventional open retropubic radical prostectomy
Undergo conventional open RRP

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

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 Name: Hormone therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458716


Locations
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United States, California
City of Hope National Medical Center (COH)
Duarte, California, United States, 91010
University of California, Irvine (UCI)
Orange, California, United States, 92868
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Investigators
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Principal Investigator: Isaac Kim Rutgers Cancer Institute of New Jersey
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Responsible Party: Isaac Yi Kim, MD, PhD, MBA, Associate Professor, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT02458716    
Other Study ID Numbers: 081403
NCI-2015-00384 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Pro20140001022 ( Other Identifier: IRB Number )
081403 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Bicalutamide
Androgens
Androgen Receptor Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists