Research subject
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
Juntendo University Hospital
Principal investigator
Shigeo Horie, Masayoshi Nagata, Naoya Nagaya
Contact (email),
Study outline
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.
  • Area of the study
    Development items
    Regulatory approval
    Main country where studies are conducted
    Led by a country abroad
    Leading country name:(USA)
    Number of participating countries, Number of participating institutions
    Number of participating countries:5, Number of participating institutions:24
    Participating countries' names
    USA, South Korea, Japan, Hong Kong, Singapore
    Study design
    Interventional study
    Development phase
    Others(P2, P3)
    Sample size
  • Website
    Registered(NCT03456843 / UMIN000036012)
    Intellectual property
    Preclinical study
    Sponsoring company
    Planning of licensing-out
    Not planned
    Domestic funding
    Funding abroad
    Yes in some of the countries(USA)
    Completed in all countries
    Procurement of investigational product
  • Steering Committee
    Development roadmap
    Not fixed yet
    Stage of the study
    In the process of patient registration
    Using a single protocol as a single study
    IRB application
    Completed in all countries
    Data management
    On-site monitoring
    Consultation with regulatory authorities
Current issues & challenges
(request for support, etc.)


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