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Anti-metabolites

Folate receptor blocker with Standard of Care for Prostate Cancer

Phase 2
Waitlist Available
Led By Michael A Liss, MD, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Have proven diagnosis of prostate cancer with confirmation by pathology report and most recent prostate biopsy procedure note.
* Commencing Androgen Deprivation Therapy (ADT) (example. intermediate/high risk localized prostate cancer starting ADT+ radiotherapy, metastatic hormone-sensitive prostate cancer (mHSPC) treated with or without androgen receptor pathway inhibitor (ARPI)- see section 4.4) as soon as able (within 2 weeks)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 18 and 24 months
Awards & highlights

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.

Who is the study for?
This trial is for men with advanced prostate cancer who are about to start Androgen Deprivation Therapy (ADT). Participants should be willing to take Trimethoprim daily for 3 months. Specific eligibility criteria were not provided, so interested individuals should contact the study organizers for more details.
What is being tested?
The study is testing if taking Trimethoprim tablets at a dose of 150mg every day can safely and effectively reduce folate levels in men undergoing ADT for advanced prostate cancer. The treatment duration is set for three months.
What are the potential side effects?
While Trimethoprim has been tested before and is generally considered safe, there may be unknown side effects that this trial aims to uncover. Commonly known side effects include allergic reactions, skin issues, and impacts on blood cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 18 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 18 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to Trimethoprim Treatment
Safety of Trimethoprim Therapy
Secondary study objectives
Levels of Red Blood Cells (RBC) Folate
Microbiome/metabolomic analysis
Prostate Specific antigen (PSA) levels in blood
+3 more

Side effects data

From 2012 Phase 4 trial • 1206 Patients • NCT02028676
9%
Malaria
5%
Neutropenia with no clinical symptoms
2%
Thrombocytopenia with no clinical symptoms
1%
Measles
1%
Anaemia with no clinical symptoms
1%
Septicaemia/bacteremia (presumptive)
1%
Clinical Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stopped Cotrimoxazole Prophylaxis
Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance
Laboratory Plus Clinical Monitoring (LCM)
Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI
Clinically Driven Monitoring (CDM)
Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance
Once-daily ABC+3TC
Twice-daily ABC+3TC
Continued Cotrimoxazole Prophylaxis

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Folate receptor blocker with Standard of CareExperimental Treatment1 Intervention
Administration of a dietary intervention to reduce folic acid at the time of standard of care androgen deprivation therapy.
Group II: Standard of Care treatmentActive Control1 Intervention
Standard of care treatment participants will have no intervention, only their prescribed androgen deprivation therapy (ex. intermediate/high risk localized prostate cancer starting ADT+ radiotherapy, metastatic hormone-sensitive prostate cancer (mHSPC) treated with or without androgen receptor pathway inhibitor (ARPI) as soon as able (within 2 weeks)

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
463 Previous Clinical Trials
91,949 Total Patients Enrolled
12 Trials studying Prostate Cancer
3,175 Patients Enrolled for Prostate Cancer
Michael A Liss, MD, PhDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
1 Previous Clinical Trials
225 Total Patients Enrolled
1 Trials studying Prostate Cancer
225 Patients Enrolled for Prostate Cancer
~33 spots leftby Jul 2026
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