Folate Study in Men With Advanced Prostate Cancer
- Conditions
- Prostate Cancer
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Male
- Target Recruitment
- 50
Inclusion Criteria:<br><br> - Have proven diagnosis of prostate cancer with confirmation by pathology report and<br> most recent prostate biopsy procedure note.<br><br> - Commencing Androgen Deprivation Therapy (ADT) (example. intermediate/high risk<br> localized prostate cancer starting ADT+ radiotherapy, metastatic hormone-sensitive<br> prostate cancer (mHSPC) treated with or without androgen receptor pathway inhibitor<br> (ARPI)- see section 4.4) as soon as able (within 2 weeks)<br><br> - Normal Complete blood count (CBC), (Red Blood Cell) RBC folate >750nmol/L and<br> homocysteine <15mcmol/L and normal creatine clearance (obtained within 30 days prior<br> to registration)<br><br> - Be age 18 or older.<br><br> - Able to stop current supplements that include folic acid.<br><br> - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status<br> 0-1<br><br> - Patient must be willing to abstain from consumption of any supplements or<br> medications containing folic acid or potassium.<br><br> - Patient must have the ability to understand and the willingness to provide written<br> informed consent.<br><br>Exclusion Criteria:<br><br> - Patients with metastatic prostate cancer commencing chemotherapy.<br><br> - Patients with known hematological disorders (including megaloblastic anemia)<br><br> - Patients with known hypersensitivity or allergy to trimethoprim<br><br> - Patients with recurrent urinary tract infections, urinary retention or neurological<br> conditions affecting bladder function.<br><br> - Unable to give informed consent.<br><br> - Age < 18.<br><br> - Unable to swallow pills.<br><br> - Prisoners.<br><br> - Patient must not have a history of renal or hepatic disease, including history of<br> hepatitis B and C<br><br> - Patient must not have undergone treatment of hormone therapy, immunotherapy,<br> chemotherapy and/or radiation for any malignancies within the past 2 years. Patients<br> with a prior or concurrent malignancy whose natural history or treatment does not<br> have the potential to interfere with the safety or efficacy assessment of the<br> investigational regimen are eligible for this trial.<br><br> - Patient must not be taking any medications that may significantly interact with<br> trimethoprim including prohibited concomitant medications.<br><br> - Patient must not receive any other investigational agents while on this study.<br><br> - Patients taking other medications that would interfere with folate metabolism (ex.<br> methotrexate)<br><br> - Patients taking memantine.<br><br> - Patients taking phenytoin.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of Trimethoprim Therapy;Adherence to Trimethoprim Treatment
- Secondary Outcome Measures
Name Time Method Serum Folate Levels;Levels of Red Blood Cells (RBC) Folate;Prostate Specific antigen (PSA) levels in blood;Urine exsomal PSMA;Testosterone levels;Microbiome/metabolomic analysis