Checking the Effects of Two Treatments on Men's Quality of Life
NCT05765500 · RecruitingThis study is looking at how two approved treatments for prostate cancer, Relugolix and Leuprolide, affect men's quality of life. Both medicines are already used to treat prostate cancer. The main goal is to see how these treatments impact daily life, blood levels, cholesterol, and blood sugar. Participants will be monitored for 12 months to track their health and well-being.
Locations and contact
This trial is running at 3 locations in the United States. 2 of them are currently recruiting.
United States3 locations · 2 recruiting
- Dana-Farber Cancer InstituteBoston, MassachusettsRecruiting
- Dana-Farber Cancer Institute at FoxboroughFoxborough, MassachusettsRecruiting
- Brigham and Women's HospitalBoston, MassachusettsNot Yet Recruiting
Who can join
Men aged 18 and older can join if they have a diagnosis of prostate cancer and are eligible for treatment with either Relugolix or Leuprolide. They should not have received certain other treatments before. The trial team will confirm who can participate based on specific health criteria.
What happens during the trial
Participants will be randomly placed into two groups. One group will take Relugolix, which they will take as a daily pill at home. The other group will receive Leuprolide through an injection at the clinic once every three months. Everyone will complete surveys about their quality of life at the start of the study and then at 3, 6, 9, and 12 months.
The trial team
The trial is led by the Dana-Farber Cancer Institute with support from the Prostate Cancer Foundation, Pfizer, and Myovant Sciences GmbH. Dr. Alicia Morgans is the principal investigator leading the study.
Important dates
The trial started on February 12, 2024, and is currently recruiting new participants. It is expected to finish by January 1, 2028.
Additional information
This is a Phase 2 trial, which means it is looking at how well the treatments work and their safety. The trial is regulated by the FDA and aims to include about 110 participants.
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