Folate Study in Men With Advanced Prostate Cancer
NCT Number: NCT06536374
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Prostate Cancer
Interventions: DRUG: Trimethoprim Tablets
Sponsor: The University of Texas Health Science Center at San Antonio
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-08
Completion Date: 2026-12-01
Locations: The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States|University Health System, San Antonio, Texas, 78229, United States

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.

Primary Outcome Measures: Safety of Trimethoprim Therapy, The primary outcome is safety using the Common Terminology Criteria for Adverse Events (CTCAE) v5. Comparing the TMP + SOC arm to the SOC alone arm will allow us to confirm if any safety issues are related to the TMP alone. Summary results will be reported as numbers of participants experiencing adverse events classified as Grade 3 and above., Baseline (start of treatment TMP+SOC or SOC) to 6 months|Adherence to Trimethoprim Treatment, Adherence is based on pill counts and drug diary logs, 3 months
Secondary Outcome Measures: Serum Folate Levels, Comparing the TMP + SOC arm to the SOC alone arm will allow us to determine effect of TMP on measures of folic acid, Baseline, 1, 2, 3 and 6 months|Levels of Red Blood Cells (RBC) Folate, Comparing the TMP + SOC arm to the SOC alone arm will allow us to determine effect of TMP on measures of folic acid, Baseline, 1, 2, 3 and 6 months|Prostate Specific antigen (PSA) levels in blood, Prostate specific antigen (PSA) is an extensively studied biomarker with prognostic implications after initiation of ADT. In patients with prostate cancer, higher PSA after initiation of ADT is associated with shorter progression free survival, Baseline, 1, 2, 3 and 6 months|Urine exsomal PSMA, A further emerging biomarker of prostate cancer is urine-derived exosome PSMA60. PSMA has been shown to be elevated in hormone resistant forms of metastatic prostate cancer60. The role of urine-derived exosome PSMA in metastatic disease and its relationship to folic acid and androgen deprivation is evolving and will be examined in this study., 1 month, 3 months and 6 months|Testosterone levels, Testosterone level is measured to determine progression free survival as part of standard of care, 12, 18 and 24 months|Microbiome/metabolomic analysis, Measure changes in gut microbiome after administration of TMP in men on ADT. Analysis of the gut microbiome in this context as a secondary aim will provide much needed data to help further understand the relationship of the gut microbiome in folic acid synthesis., 1 month, 3 months and 6 months