About this trial
This trial looks at how well standard therapy works for prostate cancer that has spread. It compares standard therapy alone to adding surgery or radiation to treat the main tumor. The goal is to see if adding these treatments helps lower the chance of the cancer growing or spreading further.
The trial's ID number is NCT03678025. It is in Phase 3, which means it is studying how well the treatment works and how safe it is. This study is not FDA-regulated for drugs but is for devices, and it aims to include about 1,273 participants.
Who can join
Men aged 18 and older can join if they have prostate cancer that has spread and an intact prostate. They should not have received certain prior treatments for prostate cancer. Patients with brain metastases are not eligible. The trial team will confirm who can join.
Conditions
Castration Levels of Testosterone, Metastatic Prostatic Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed in one of two groups. One group will get standard therapy only. The other group will receive standard therapy plus surgery to remove the prostate or radiation therapy. Everyone will receive treatments based on their assigned group.
Where
This trial is running at 334 locations in the United States. 293 of them are currently recruiting.
21st Century Oncology-Pontiac
Pontiac, Michigan
Adams Cancer Center
Gettysburg, Pennsylvania
Albany Medical Center
Albany, New York
Ascension Saint Mary's Hospital
Saginaw, Michigan
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin
Aspirus Regional Cancer Center
Wausau, Wisconsin
Atlanta VA Medical Center
Decatur, Georgia
The first 8 of 334 sites are listed here. The registry record has the full list.