Status:
RECRUITING
Study to Detect Changes in Urinary and Gut Microbiome During Androgen Deprivation Therapy and Radiation Therapy in Patients With Prostate Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage I Prostate Cancer AJCC v7
Stage II Prostate Cancer AJCC v7
Eligibility:
MALE
18+ years
Brief Summary
This study collects urine and stool samples to determine the ability to identify changes in the microbiome (bacteria, fungi, and viruses that live in the gut and urine) of patients with prostate cance...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the feasibility of identifying changes in urine and gut microbiomes during androgen deprivation therapy and radiation therapy for prostate cancer. SECONDARY OBJECT...
Eligibility Criteria
Inclusion
- Pathologically confirmed prostate cancer, with a plan to receive radiation therapy for either definitive (cohort A) or salvage (cohort B) therapy. Patients without planned androgen deprivation therapy (ADT) will be accrued to cohort C
- Cohort A will be restricted to Gleason grade group 3 or higher (4+3 or 8-10) so that androgen deprivation will be indicated
- Cohort B will not be restricted by Gleason grade but will require rising prostate-specific antigen (PSA) and a plan for ADT with salvage radiation
- Cohort C will be prostate cancer patients in whom definitive or salvage radiation is planned without ADT
- Patients must be age 18 or older
- Willing to provide urine and stool samples at specified time points
Exclusion
- Men with inflammatory bowel disease or pre-existing cystitis will be excluded
Key Trial Info
Start Date :
April 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 29 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04775355
Start Date
April 14 2021
End Date
July 29 2026
Last Update
September 16 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010