Study on Trimethoprim for Lowering Folate Levels in Men with Advanced Prostate Cancer

Sponsor: The University of Texas Health Science Center at San Antonio

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06536374

Provider View

This study is exploring whether taking Trimethoprim daily for three months can safely and effectively lower folate levels in men undergoing Androgen Deprivation Therapy (ADT) for advanced prostate cancer.

Patient Parameters

Program Overview

The aim of this study is to determine if Trimethoprim, taken at a dose of 150mg daily, can help reduce folate levels in men with advanced prostate cancer who are starting Androgen Deprivation Therapy (ADT). Researchers want to understand the effects, both positive and negative, of this drug on patients and its impact on the disease. While Trimethoprim's safety has been tested in previous studies, some side effects may still be unknown.

Description

Participants in this study will need to attend about 5 to 7 visits with the research team. These visits may coincide with regular hospital or clinic appointments every 1 to 3 months as part of standard care. If you are in the treatment group, you might have to attend 2 extra visits specifically for research purposes. Before joining the study, you will need to stop taking any supplements or medications that contain folic acid or potassium.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of prostate cancer, verified by a pathology report and recent biopsy.
  • Starting Androgen Deprivation Therapy (ADT) soon, within 2 weeks, for conditions like intermediate/high risk localized prostate cancer or metastatic hormone-sensitive prostate cancer.
  • Normal blood test results, including red blood cell folate levels above 750 nmol/L, homocysteine levels below 15 mcmol/L, and normal kidney function.
  • Be 18 years or older.
  • Able to stop taking supplements that contain folic acid.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Willing to avoid supplements or medications with folic acid or potassium.
  • Able to understand and willing to sign a written consent form.

Exclusion Criteria

  • Have metastatic prostate cancer and starting chemotherapy.
  • Have blood disorders like megaloblastic anemia.
  • Allergic to trimethoprim.
  • Have frequent urinary tract infections, urinary retention, or neurological conditions affecting bladder function.
  • Unable to give informed consent.
  • Under 18 years old.
  • Unable to swallow pills.
  • Currently in prison.
  • Have a history of kidney or liver disease, including hepatitis B or C.
  • Have had hormone therapy, immunotherapy, chemotherapy, or radiation for any cancer in the past 2 years, unless it doesn't affect the study's safety or effectiveness.
  • Taking medications that interact with trimethoprim or affect folate metabolism, like methotrexate, memantine, or phenytoin.
  • Participating in another study with investigational drugs.

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