Trimethoprim for Prostate Cancer

Recruiting at 1 trial location

Overseen By Brandi Weaver, BS

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Methotrexate, Memantine, Phenytoin

Disqualifiers: Chemotherapy, Hematological disorders, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 3 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially those containing folic acid or potassium, and any that might interact with trimethoprim. It's important to discuss your current medications with the trial team to see if any changes are needed.

How does the drug Trimethoprim differ from other treatments for prostate cancer?

Trimethoprim is unique in the context of prostate cancer treatment as it is primarily an antibiotic used to treat bacterial infections, unlike other drugs like cyclophosphamide or methotrexate, which are traditional chemotherapy agents. Its use in prostate cancer is novel and not part of the standard treatment options, which typically involve hormone therapy or chemotherapy with drugs specifically tested for cancer. ^{1 2 3 4 5}

Who Is on the Research Team?

Michael A. Liss

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Normal Complete blood count (CBC), RBC folate >750nmol/L, homocysteine <15mcmol/L, and normal creatine clearance (obtained within 30 days prior to registration)

Ability to understand and willingness to provide written informed consent

Able to stop current supplements that include folic acid

Exclusion Criteria

I am under 18 years old.

Receiving any other investigational agents while on this study

I am starting chemotherapy for my metastatic prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Trimethoprim, 150mg daily for 3 months, alongside standard of care androgen deprivation therapy

3 months

5-7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of serum folate levels, RBC folate, PSA levels, and microbiome analysis

6 months

Long-term Follow-up

Participants' testosterone levels are monitored to determine progression-free survival

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Trimethoprim

Trial Overview 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.

How Is the Trial Designed?

Group I: Folate receptor blocker with Standard of Care Experimental Treatment 1 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 treatment Active Control 1 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)

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Citations

1. France pubmed.ncbi.nlm.nih.gov

[Cancer of the prostate: current status of chemotherapy]. [2013]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Chemotherapy of the transplantable adenocarcinoma (R-3327) of the Copenhagen rat. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of flutamide and Emcyt in hormone-refractory metastatic prostatic cancer. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Radiochemotherapy and simultaneous hormonal therapy of locally advanced prostatic carcinoma]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy of prostatic cancer. [2013]