NCT03678025 · SWOG Cancer Research Network
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
What this study is about
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body.
View original scientific description
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
Interventions
DRUG
Abiraterone
Given PO
DRUG
Bicalutamide
Given PO
DRUG
Degarelix
Given via injection
DRUG
Docetaxel
intravenous
DRUG
Flutamide
Given PO
DRUG
Goserelin Acetate
Given SC
DRUG
Histrelin Acetate
Receive SC
DRUG
Leuprolide Acetate
Receive SC or IM
DRUG
Nilutamide
Given PO
PROCEDURE
Orchiectomy
Undergo bilateral orchiectomy
DRUG
Prednisone
Given PO
OTHER
Quality-of-Life Assessment
Ancillary studies
RADIATION
Radiation Therapy
Standard radiation
PROCEDURE
Radical Prostatectomy
Standard surgery
DRUG
Triptorelin
injection
Primary outcome measures
Overall survival (OS)
Time frame: From date of randomization to date of death due to any cause, assessed up to 8 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 t
Where
- Gilbert, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Antioch, California
- Clovis, California
- Duarte, California
- Dublin, California
- Fremont, California
- Fresno, California
- La Jolla, California
And 244 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 11, 2025 · Source of record for eligibility and locations