Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer

Phase 2Active Not RecruitingNCT03456843

Yale University190 enrolled

Overview

This is a phase 2.5 international, multi-institution, randomized clinical trial to evaluate the potential therapeutic effect of CRP combined with the BST in men with mPCa prospectively. Such hybrid design permits the inclusion of the patients who have accrued to the phase 2 investigation to phase 3 trial, thereby decreasing the number of patients needed overall (5-7). In the initial phase 2 study, we plan to accrue 190 patients.

PRIMARY OBJECTIVES: I. To assess the clinical benefit of combining radical surgery - cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) - to be determined by the treating physician in men with newly diagnosed clinical mPCa. SECONDARY OBJECTIVES: I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific survival, overall survival, complication rates, and quality of life (QOL) in patients with mPCa. II. To determine the transcription levels of bone morphogenetic protein -6 (BMP-6) and transforming growth factor-beta (TGF-?). OUTLINE: Participants are randomized to 1 of 2 arms. ARM I (Control Group): BST - to be determined by the treating physician (ADT +/- docetaxel at the discretion of the treating physician). ARM II: CRP + BST

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

190

Conditions

Stage IV Prostate Adenocarcinoma AJCC v7

Interventions

Antiandrogen TherapyDRUG

To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.

DocetaxelDRUG

To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.

Laboratory Biomarker AnalysisOTHER

Correlative studies

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven adenocarcinoma of the prostate * Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation * Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis. * If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET \[positron emission tomography\], bone scan and MRI, modality at the discretion of the treating physician) * No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.) * Give informed consent * Prostate deemed resectable by surgeon * Plans to start or has already started ADT no longer than 6 months prior to consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Hemoglobin (HgB) \>= 9 g/dL compatible for surgery * Platelets \> 80,000/mcL compatible for surgery * Aspartate aminotransferase (AST) =\< 2x upper limit of normal (ULN) compatible for surgery * Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery Exclusion Criteria: * Refuses to give informed consent * Deemed to have unresectable disease by surgeon * Received ADT for more than 6 months prior to consent * Life expectancy of less than 6 months prior to consent * Active spinal cord compression * Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent * Previous local therapy for prostate cancer * Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent

Locations (16)

City of Hope

Duarte, California, United States

University of California, Irvine

Irvine, California, United States

University of Southern California

Outcomes

Primary Outcomes

Failure-free survival (FFS)

Failure is defined as any one of the following events: PSA progression, clinical progression, radiographic progression, or death. The % of men who fail within 2 years of randomization will be compare between the two groups using a one-sided log-rank test.

Time frame: At 2 years

Secondary Outcomes

Cancer-specific survival

Time frame: Up to 2 years

Overall complication rate

Time frame: Up to 2 years

Time to biochemical progression

Time frame: Up to 2 years

Overall survival

Time frame: Through study completion, a minimum of 4 years

Data from ClinicalTrials.gov

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