Standard Systemic Tx w/out Definitive Tx in Mets Prostate Cancer

July 16, 2019

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer).

  • Clinical Trial Information

    Trial Contact: Walton, Sherri; Cevallos, Claudia

    Trial Phone: 321.841.1907 ; 321-841-2684

  • IRB No: S1802

    Protocol Abbrev: CIRB S1802

    Principal Investigator: Daniel Ari Landau, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: S1802

    Treatment: Drug: Abiraterone Drug: Bicalutamide Drug: Degarelix Drug: Docetaxel Drug: Flutamide Drug: Goserelin Acetate Drug: Histrelin Acetate Drug: Leuprolide Acetate Drug: Nilutamide Procedure: Orchiectomy Drug: Prednisone Other: Quality-of-Life Assessment Radiation: Radiation Therapy Procedure: Radical Prostatectomy Drug: Triptorelin

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT03678025

  • Objective

    To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone

  • Key Eligibility

    1. All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).
    2. Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, HIFU, cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).