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Anti-metabolites

Trimethoprim 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

Proven diagnosis of prostate cancer with confirmation by pathology report and most recent prostate biopsy procedure note

Commencing Androgen Deprivation Therapy (ADT) as soon as able (within 2 weeks)

Must not have

Age < 18

Metastatic prostate cancer commencing chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12, 18 and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate whether taking Trimethoprim, 150mg daily for 3 months, can safely reduce folate levels during Androgen Deprivation Therapy in men with advanced prostate cancer.

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

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My prostate cancer diagnosis is confirmed by a pathology report.

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I will start hormone therapy for my cancer within 2 weeks.

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I am 18 years old or older.

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I am willing to stop taking supplements or medications with folic acid or potassium.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am starting chemotherapy for my metastatic prostate cancer.

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I cannot swallow pills.

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I have a history of kidney or liver disease, including hepatitis B or C.

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I am currently taking phenytoin.

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I have a blood disorder, such as megaloblastic anemia.

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I have frequent UTIs, trouble emptying my bladder, or a nerve condition affecting my bladder.

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I am unable to understand and agree to the study's details on my own.

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I haven't had cancer treatment like hormone, immunotherapy, chemo, or radiation in the last 2 years.

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I am not on medications that interact with trimethoprim.

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I am not on medications that affect folate metabolism.

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I am currently taking memantine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12, 18 and 24 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 17Eligibility criteria met