A Phase II, Open Label, Randomized Controlled Pilot Study Evaluating Trimethoprim in Patients Commencing Androgen Deprivation Therapy for Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Trimethoprim Tablets
- Conditions
- Prostate Cancer
- Sponsor
- University of California, San Diego
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Safety of Trimethoprim
- Status
- Not yet recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Michael Liss
Associate Professor
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Trimethoprim plus androgen deprivation therapy
Administration of trimethoprim to reduce folic acid levels at the time of standard of care androgen deprivation therapy.
Intervention: Trimethoprim Tablets
Outcomes
Primary Outcomes
Safety of Trimethoprim
Time Frame: From first dose of study therapy through 1 month after completion of study therapy.
Proportion of participants with adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).