SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined with Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men with Newly Diagnosed Metastatic Prostate Cancer. (Multi-center)

Purpose/Specific Objectives

1.1 Primary Objective(s)

To assess the clinical benefit of combining radical surgery cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed clinical N1, M1a, or M1b metastatic prostate cancer (mPCa).

1.2 Secondary Objective(s)

There are two secondary objectives: clinical and tissue correlates.

The clinical secondary objective is to determine the impact of CRP+BST on time to PSA nadir, biochemical progression, clinical progression, cancer-specific survival, overall survival, complication rates, and quality of life (QOL) in patients with mPCa.

The tissue correlate secondary objective is to identify patients most likely to benefit from CRP+BST by profiling mutations and gene expression.

1.3 Primary Hypothesis/hypotheses

The primary hypothesis is that CRP in men with mPCa will increase survival by rendering the systemic therapy more effective.

1.4 Secondary Hypothesis/Hypotheses

There are four secondary hypotheses.

PSA nadir < 0.2 ng/ml at six months after randomization will predict failure-free survival (FFS) in men with mPCa.

CRP is safe in men with clinical N1, M1a, or M1b prostate cancer.

CRP will improve the quality of life by mitigating local urinary symptoms.

There is a unique mutation and/or gene expression signature that predicts patients who are most likely to benefit from combining CRP with BST.

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