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Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
Sponsor: Yale University
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 spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.
Official title: 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
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2018-03-20
Completion Date
2027-03
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
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.
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo cytoreductive radical prostatectomy
Locations (16)
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