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; Manchola-Orozco, Carolina
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
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
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).