Spots Global Cancer Trial Database for Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
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Trial Identification
Brief Title: Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic 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
Study ID: NCT03456843
Conditions
Study Description
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 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.
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 clinical metastatic prostate cancer (mPCa). SECONDARY OBJECTIVES: I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
University of California, Irvine, California, United States
University of Southern California, Los Angeles, California, United States
Yale University, New Haven, Connecticut, United States
University of Chicago, Chicago, Illinois, United States
University of Louisville, Louisville, Kentucky, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Unniversity of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Swedish Medical Services, Seattle, Washington, United States
Epworth Healthcare, East Melbourne, , Australia
Chinese University of Hong Kong, Hong Kong, , China
Kyoto University, Sako, Kyoto, Japan
Kindai University, Ōsaka-sayama, Osaka, Japan
Akita University, Akita, , Japan
Juntendo University, Tokyo, , Japan
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
National Taiwan University Hospital, Taipei, , Taiwan
Contact Details
Name: Isaac Kim
Affiliation: Yale University
Role: PRINCIPAL_INVESTIGATOR
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