Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536374
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Folate Study in Men With Advanced Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Open Label Randomized Controlled Pilot Study Evaluating Trimethoprim in Patients Commencing Androgen Deprivation Therapy for Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
This study will help find out what effects good andor 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 hospitalclinic 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
It may be necessary for participants to return to the hospitalclinic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None