Folate Study in Men With Advanced Prostate Cancer

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Folate Study, is looking to see if a medication called Trimethoprim, taken daily for three months, is safe and effective for men with advanced prostate cancer who are starting a treatment called Androgen Deprivation Therapy (ADT). The researchers want to understand how this drug affects folate levels in the body and its overall impact on prostate cancer. While Trimethoprim has been tested before, this study aims to learn more about potential side effects and benefits that may not have been identified in earlier research.

To participate in this trial, men aged 18 and older must have a confirmed diagnosis of prostate cancer and be starting ADT within two weeks. They should also have certain blood test results, including normal folate levels. Participants will need to stop taking any supplements that contain folic acid and should be in good health overall. It's important to note that individuals with certain health conditions or those taking specific medications may not be eligible to join. If you qualify, you can expect regular check-ins to monitor your health and how you’re responding to the treatment. This study is not yet recruiting participants, but it aims to provide valuable insights into managing advanced prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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)
• • Normal Complete blood count (CBC), (Red Blood Cell) RBC folate \>750nmol/L and homocysteine \<15mcmol/L and normal creatine clearance (obtained within 30 days prior to registration)
• • Be age 18 or older.
• • Able to stop current supplements that include folic acid.
• • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• • Patient must be willing to abstain from consumption of any supplements or medications containing folic acid or potassium.
• • Patient must have the ability to understand and the willingness to provide written informed consent.
• Exclusion Criteria:
• • Patients with metastatic prostate cancer commencing chemotherapy.
• • Patients with known hematological disorders (including megaloblastic anemia)
• • Patients with known hypersensitivity or allergy to trimethoprim
• • Patients with recurrent urinary tract infections, urinary retention or neurological conditions affecting bladder function.
• • Unable to give informed consent.
• • Age \< 18.
• • Unable to swallow pills.
• • Prisoners.
• • Patient must not have a history of renal or hepatic disease, including history of hepatitis B and C
• • Patient must not have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation 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.
• • Patient must not be taking any medications that may significantly interact with trimethoprim including prohibited concomitant medications.
• • Patient must not receive any other investigational agents while on this study.
• • Patients taking other medications that would interfere with folate metabolism (ex. methotrexate)
• • Patients taking memantine.
• • Patients taking phenytoin.