Clinical trial · Interventional
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
NCT06536374CI-TRIAL-00097149not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trimethoprim Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trimethoprim plus androgen deprivation therapy
- description
- Administration of trimethoprim to reduce folic acid levels at the time of standard of care androgen deprivation therapy.
- interventionNames
- Drug: Trimethoprim Tablets
- type
- NO_INTERVENTION
- label
- Standard of Care treatment
- description
- Standard of care treatment participants will have no intervention, only their prescribed androgen deprivation therapy.
Primary outcomes (1)
- measure
- Safety of Trimethoprim
- timeFrame
- From first dose of study therapy through 1 month after completion of study therapy.
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.