Prostate CancerPhase 2NCT06536374
Folate Study in Men With Advanced Prostate Cancer
A Phase 2 study testing Trimethoprim Tablets in people with Prostate Cancer, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Trimethoprim Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- Known hypersensitivity or allergy to trimethoprim.
- Hematological disorders (including megaloblastic anemia).
- Commencing chemotherapy for metastatic prostate cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Diego
La Jolla, California, 92093
Michael A Liss, MD, PhD, (858) 822-5354, cancerCTO@health.ucsd.edu
Alexandrea Cronin, (858) 822-5354, cancerCTO@health.ucsd.edu
About this study
Official title: A Phase II, Open Label, Randomized Controlled Pilot Study Evaluating Trimethoprim in Patients Commencing Androgen Deprivation Therapy for Prostate Cancer
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.
Read the 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 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
- Prostate Cancer
- Being tested
- Trimethoprim Tablets
- Keywords
- Androgen deprivation therapy, Folic Acid
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim TabletsDrug
Trimethoprim 150mg is administered once daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Trimethoprim plus androgen deprivation therapy | Experimental | Administration of trimethoprim to reduce folic acid levels at the time of standard of care androgen deprivation therapy. Receives: Drug: Trimethoprim Tablets |
| Standard of Care treatment | No intervention | Standard of care treatment participants will have no intervention, only their prescribed androgen deprivation therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From first dose of study therapy through 1 month after completion of study therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Liss, University of California, San Diego
- Investigators
- Michael A Liss, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536374
- Sponsor's protocol ID
- 812072
- Status last verified
- Nov 2025
- First submitted
- 30 Jul 2024
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Randomized Controlled Pilot Study Evaluating Trimethoprim in Patients Commencing Androgen Deprivation Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT06536374
- Acronym / sponsor ID
- 812072
- Conditions
- Prostate Cancer
- Keywords
- Androgen deprivation therapy, Folic Acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Trimethoprim plus androgen deprivation therapy | Experimental | Drug: Trimethoprim TabletsAdministration of trimethoprim to reduce folic acid levels at the time of standard of care androgen deprivation therapy. |
| Standard of Care treatment | No intervention | –Standard of care treatment participants will have no intervention, only their prescribed androgen deprivation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim TabletsTrimethoprim 150mg is administered once daily for 3 months | Drug | Trimethoprim plus androgen deprivation therapy |
Primary outcome
Safety of Trimethoprim
Time frame: From first dose of study therapy through 1 month after completion of study therapy.
Proportion of participants with adverse events and serious adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
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Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
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A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 3
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 2
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation, Metastatic Prostate Neuroendocrine Carcinoma
RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael A Liss, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trimethoprim Tablets in people with Prostate Cancer, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael A Liss, MD, PhD ((858) 822-5354, cancerCTO@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Trimethoprim (time frame: From first dose of study therapy through 1 month after completion of study therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.