Status:
RECRUITING
Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage IV Prostate Adenocarcinoma AJCC v7
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has s...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the clinical benefit of combining radical surgery cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed clinica...
Eligibility Criteria
Inclusion
- 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 antiandrogen therapy (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
- 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
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT03456843
Start Date
March 20 2018
End Date
March 1 2027
Last Update
November 17 2025
Active Locations (17)
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1
City of Hope
Duarte, California, United States, 91010
2
University of California, Irvine
Irvine, California, United States, 92697
3
University of Southern California
Los Angeles, California, United States, 90033
4
Yale University
New Haven, Connecticut, United States, 06519