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Trial Title:
Folate Study in Men With Advanced Prostate Cancer
NCT ID:
NCT06536374
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Trimethoprim
Conditions: Keywords:
Androgen deprivation therapy
Folic Acid
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This study is a Phase II, open label, randomized controlled trial. Subjects will be
randomized 1:1 to either Trimethoprim (TMP) + (Standard of Care) SOC or SOC alone
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trimethoprim Tablets
Description:
Trimethoprim 150mg is administered once daily for 3 months
Arm group label:
Folate receptor blocker with Standard of Care
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.
Detailed description:
While taking part in this study, participants will be asked to attend approximately 5-7
visits with the researchers or study staff.
It may be necessary for participants to return to the hospital/clinic every 1-3 months as
part of their regular care. Research procedures will be completed at the same time as
these routine standard of care visits. Subjects randomized to the treatment arm may be
asked to attend 2 additional research only visits.
Participants will be asked to stop taking any supplements or medications containing folic
acid or potassium prior to enrolling in the study
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas Health Science Center at San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Contact:
Last name:
Michael A Liss, MD, PhD
Phone:
210-567-5676
Email:
Liss@uthscsa.edu
Contact backup:
Last name:
Brandi Weaver, BA
Phone:
210-567-0178
Email:
WeaverB@uthscsa.edu
Investigator:
Last name:
Michael Liss, MD
Email:
Principal Investigator
Facility:
Name:
University Health System
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Contact:
Last name:
Michael A Liss, MD, PhD
Phone:
210-567-5640
Email:
liss@uthscsa.edu
Contact backup:
Last name:
Brandi Weaver
Phone:
210-450-8827
Email:
weaverb@uthscsa.edu
Start date:
November 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
The University of Texas Health Science Center at San Antonio
Agency class:
Other
Source:
The University of Texas Health Science Center at San Antonio
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06536374
