Folate Study in Men With Advanced Prostate Cancer

NCT06536374 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 812072
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Prostate Cancer

Keywords

Androgen deprivation therapy; Folic Acid

Outcome Measures

Primary Outcomes (1)

• Safety of Trimethoprim

  Proportion of participants with adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).

  From first dose of study therapy through 1 month after completion of study therapy.

Study Arms (2)

Trimethoprim plus androgen deprivation therapy

EXPERIMENTAL

Administration of trimethoprim to reduce folic acid levels at the time of standard of care androgen deprivation therapy.

Drug: Trimethoprim Tablets

Standard of Care treatment

NO INTERVENTION

Standard of care treatment participants will have no intervention, only their prescribed androgen deprivation therapy.

Interventions

Trimethoprim Tablets DRUG

Trimethoprim 150mg is administered once daily for 3 months

Trimethoprim plus androgen deprivation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Trimethoprim

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael A Liss, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Liss, MD, PhD

CONTACT

(858) 822-5354; cancerCTO@health.ucsd.edu

Alexandrea Cronin

CONTACT

(858) 822-5354; cancerCTO@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is a Phase II, open label, randomized controlled trial. Subjects will be randomized 1:1 to either Trimethoprim (TMP) + androgen deprivation therapy per standard of care or to androgen deprivation therapy alone.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)