Status:
NOT_YET_RECRUITING
Folate Study in Men With Advanced Prostate Cancer
Lead Sponsor:
University of California, San Diego
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 pr...
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 neces...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥ 18 years.
- 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.
- Prostate cancer treatment naïve.
- 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.
- Hemoglobin ≥ 11 g/dL.
- Red blood cell folate \> 750 nmol/L.
- Homocysteine \< 15 micromol/L.
- Creatine clearance within the normal range.
- Eastern Cooperative Oncology Group performance status 0-1
- Stated willingness to abstain from consumption of any supplements or medications containing folic acid or potassium.
- Ability to take oral medications and be willing to adhere to trimethoprim and androgen deprivation therapy regimens.
- For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner.
- Agreement to adhere to lifestyle considerations described in the protocol throughout study duration.
- EXCLUSION CRITERIA
- Current use of memantine, phenytoin, and any medications that may significantly interact with TMP, including prohibited concomitant medications listed in the protocol.
- Current use of medications that would interfere with folate metabolism (for example, methotrexate).
- Treatment with another investigational drug while on this study.
- 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.
- History of renal or hepatic disease, including history of hepatitis B and C.
- Recurrent urinary tract infections, urinary retention, or neurological conditions affecting bladder function.
- Known hypersensitivity or allergy to trimethoprim.
- Hematological disorders (including megaloblastic anemia).
- Commencing chemotherapy for metastatic prostate cancer.
Exclusion
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06536374
Start Date
June 1 2026
End Date
December 1 2027
Last Update
November 12 2025
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92093