Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
NCT ID: NCT03456843
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
190 participants
INTERVENTIONAL
2018-03-20
2027-03-31
Brief Summary
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Detailed Description
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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 clinical metastatic prostate cancer (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: Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.
ARM II: Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel prior to surgery at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 6 months from time of progression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (ADT, docetaxel)
Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Antiandrogen Therapy
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.
Docetaxel
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.
Arm II (ADT, radical prostatectomy, docetaxel)
Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel prior to surgery at the discretion of the treating physician.
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo cytoreductive radical prostatectomy
Antiandrogen Therapy
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.
Docetaxel
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.
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo cytoreductive radical prostatectomy
Antiandrogen Therapy
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.
Docetaxel
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Isaac Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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City of Hope
Duarte, California, United States
University of California, Irvine
Irvine, California, United States
University of Southern California
Los Angeles, California, United States
Yale University
New Haven, Connecticut, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Swedish Medical Services
Seattle, Washington, United States
Epworth Healthcare
East Melbourne, Australia, Australia
Chinese University of Hong Kong
Hong Kong, , China
Kindai University
Ōsaka-sayama, Osaka, Japan
Akita University
Akita, , Japan
Juntendo University
Tokyo, , Japan
National Cancer Center
Goyang-si, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Samsung Medical Center
Seoul, , South Korea
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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NCI-2018-00047
Identifier Type: REGISTRY
Identifier Source: secondary_id
081707
Identifier Type: OTHER
Identifier Source: secondary_id
Pro20170001506
Identifier Type: OTHER
Identifier Source: secondary_id
2000031290
Identifier Type: -
Identifier Source: org_study_id
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