Folate Study in Men With Advanced Prostate Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06536374
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trimethoprim Tablets — DRUG
    Trimethoprim 150mg is administered once daily for 3 months

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trimethoprim plus androgen deprivation therapy
    Administration of trimethoprim to reduce folic acid levels at the time of standard of care androgen deprivation therapy.
  • No Intervention: Standard of Care treatment
    Standard of care treatment participants will have no intervention, only their prescribed androgen deprivation therapy.

Primary Outcome Measure

Safety of Trimethoprim [ Time Frame: From first dose of study therapy through 1 month after completion of study therapy. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Michael A Liss, MD, PhD
(858) 822-5354
Alexandrea Cronin
(858) 822-5354

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