What is the Purpose of this Study?
The purpose of this study is to compare the effects of adding either prostate removal surgery or radiation therapy to standard systemic therapy for the treatment of metastatic prostate cancer. Researchers aim to determine whether they can lower the chance of the patient’s prostate cancer growing or spreading by adding either prostate removal surgery or radiation therapy to the usual combination of drugs. The addition of surgery or radiation therapy to the usual treatment could help patients live longer but may cause side effects. Participants will be randomly assigned to 1 of 2 groups. One group will receive standard systemic therapy until their disease gets worse or side effects are too great. The other group will continue to receive standard systemic therapy but will also either have surgery to remove the prostate or receive radiation therapy. The study doctor will help determine whether the patient is a good candidate for either surgery or radiation.
Eligibility
- * STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: 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).
- * STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound \[HIFU\], 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).
- * STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride \[NaF\], prostate-specific membrane antigen \[PSMA\], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid \[FACBC\], carbon \[C\]11) but not conventional imaging (technetium \[Tc\]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.
- * STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.
Where can I participate?
- CS Cancer at Beverly Hills : Maria Tarallo
- CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo
More about this Clinical Trial
What is the full name of this clinical trial?
S1802: Phase III Randomized Trial of Standard Systemic Therapy Versus Standard Systemic Therapy Plus Definitive Treatment of the Primary Tumor in Metastatic Prostate Cancer.