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A Phase II, Open Label, Randomized Controlled Pilot Study Evaluating Trimethoprim in Patients Commencing Androgen Deprivation Therapy for Prostate Cancer
The researchers hope to learn if Trimethoprim, 150mg taken daily for 3 months, is a safe and effective way to reduce folate levels at time of Androgen Deprivation Therapy (ADT) in men with advanced prostate cancer. This study will help find out what effects, good and/or bad, this drug has on people who take it and on its effect on the disease. The safety of this drug in humans has been tested in prior research studies; however, some side effects may not yet be known.
While taking part in this study, participants will be asked to attend approximately 4 to 7 visits - depending on what randomized arm they are in - with the researchers or study staff. It may be necessary for participants to return to the hospital/clinic every 1-3 months as part of their regular care. Research procedures will be completed at the same time as these routine standard of care visits. Participants will be asked to stop taking any supplements or medications containing folic acid or potassium prior to enrolling in the study.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
University of California, San Diego
La Jolla, California, United States
Start Date
June 1, 2026
Primary Completion Date
December 1, 2027
Completion Date
December 1, 2027
Last Updated
November 12, 2025
50
ESTIMATED participants
Trimethoprim Tablets
DRUG
Lead Sponsor
University of California, San Diego
NCT05691465
NCT04550494
Data Source & Attribution
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