Prostate Cancer Clinical Trial

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

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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.

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Full 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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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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

26

Study ID:

NCT02458716

Recruitment Status:

Completed

Sponsor:

Rutgers, The State University of New Jersey

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There are 3 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

26

Study ID:

NCT02458716

Recruitment Status:

Completed

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

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