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

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