About this trial
This study looks at how well a new treatment called lutetium (177Lu) vipivotide tetraxetan helps men with oligometastatic prostate cancer. This type of cancer has spread but is still limited to a few spots. The goal is to see if this treatment can help control the cancer from getting worse and to delay the need for other treatments while maintaining a good quality of life.
This is a Phase 3 trial, which means it's looking at how well the treatment works and how safe it is. The study plans to include about 450 people and is regulated by the FDA.
Who can join
Men aged 18 to 100 can join this study. They must have prostate cancer that has come back after treatment and show specific signs on scans. Some other health conditions may stop someone from joining. The trial team will check to see who can participate.
Condition
Oligometastatic Prostate Cancer (OMPC)
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 receive the new treatment after a special radiation therapy. The other group will only have radiation therapy followed by observation. Everyone will have regular check-ups to monitor their condition and response to treatment.
Where
This trial is running at 41 locations in the United States. 40 of them are currently recruiting.
Associated Med Professionals of NY
Syracuse, New York
BAMF Health
Grand Rapids, Michigan
Beth Israel Deaconess Med Ctr
Boston, Massachusetts
Blue Ridge Cancer Center
Wytheville, Virginia
Cancer Specialists of North Florida
Jacksonville, Florida
Carolina Regional Cancer Center
Myrtle Beach, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina
Coastal Cancer Center
Conway, South Carolina
The first 8 of 41 sites are listed here. The registry record has the full list.