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



Status:Active, not recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:March 2015
End Date:August 2019

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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.

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.

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
We found this trial at
6
sites
1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Daniel Eun, MD
Temple University Temple University is many things to many people. A place to pursue life's...
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Duarte, California 91010
Principal Investigator: Bertram Yuh, MD
Phone: 626-256-4673
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New Brunswick, New Jersey 08903
Principal Investigator: Isaac Y. Kim
Phone: 732-235-2043
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Orange, California 92868
Principal Investigator: Thomas Ahlering, MD
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Philadelphia, Pennsylvania 19104
Principal Investigator: David I Lee, MD
Phone: 215-662-8699
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Seattle, Washington 98107
Principal Investigator: James Porter, MD
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Seattle, WA
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