RightFit
Not yet recruitingPhase 2

Folate Study in Men With Advanced Prostate Cancer

A Phase II, Open Label, Randomized Controlled Pilot Study Evaluating Trimethoprim in Patients Commencing Androgen Deprivation Therapy for Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

INCLUSION CRITERIA 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age ≥ 18 years. 4. Proven diagnosis of prostate cancer (intermediate unfavorable risk, high risk, very high risk localized per the 2025 NCCN guidelines), or metastatic hormone-sensitive prostate cancer with confirmation by pathology report and most recent prostate biopsy procedure note. 5. Prostate cancer treatment naïve. 6. Commencing androgen deprivation therapy for prostate cancer within 4 weeks of enrollment in the study. Note that radiotherapy and androgen receptor pathway inhibitors, apart from abiraterone, are allowed in both arms. 7. Hemoglobin ≥ 11 g/dL. 8. Red blood cell folate \> 750 nmol/L. 9. Homocysteine \< 15 micromol/L. 10. Creatine clearance within the normal range. 11. Eastern Cooperative Oncology Group performance status 0-1 12. Stated willingness to abstain from consumption of any supplements or medications containing folic acid or potassium. 13. Ability to take oral medications and be willing to adhere to trimethoprim and androgen deprivation therapy regimens. 14. For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner. 15. Agreement to adhere to lifestyle considerations described in the protocol throughout study duration. EXCLUSION CRITERIA 1. Current use of memantine, phenytoin, and any medications that may significantly interact with TMP, including prohibited concomitant medications listed in the protocol. 2. Current use of medications that would interfere with folate metabolism (for example, methotrexate). 3. Treatment with another investigational drug while on this study. 4. Treatment with hormone therapy, immunotherapy, chemotherapy and/or radiation therapy for any malignancies within the past 2 years. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 5. History of renal or hepatic disease, including history of hepatitis B and C. 6. Recurrent urinary tract infections, urinary retention, or neurological conditions affecting bladder function. 7. Known hypersensitivity or allergy to trimethoprim. 8. Hematological disorders (including megaloblastic anemia). 9. Commencing chemotherapy for metastatic prostate cancer.

Study sites (1)

CA