Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2026-06-30
2027-12-31
Brief Summary
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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.
Detailed Description
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It may be necessary for participants to return to the hospital/clinic every 1-3 months as part of their regular care. Research procedures will be completed at the same time as these routine standard of care visits. Participants will be asked to stop taking any supplements or medications containing folic acid or potassium prior to enrolling in the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trimethoprim plus androgen deprivation therapy
Administration of trimethoprim to reduce folic acid levels at the time of standard of care androgen deprivation therapy.
Trimethoprim Tablets
Trimethoprim 150mg is administered once daily for 3 months
Standard of Care treatment
Standard of care treatment participants will have no intervention, only their prescribed androgen deprivation therapy.
No interventions assigned to this group
Interventions
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Trimethoprim Tablets
Trimethoprim 150mg is administered once daily for 3 months
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Michael Liss
Associate Professor
Principal Investigators
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Michael A Liss, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California, San Diego
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Michael A Liss, MD, PhD
Role: primary
Alexandrea Cronin
Role: backup
Other Identifiers
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812072
Identifier Type: -
Identifier Source: org_study_id