Study to Detect Changes in Urinary and Gut Microbiome During Androgen Deprivation Therapy and Radiation Therapy in Patients With Prostate Cancer

Launched by CITY OF HOPE MEDICAL CENTER · Feb 25, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how certain treatments for prostate cancer, specifically androgen deprivation therapy (which lowers testosterone) and radiation therapy, affect the balance of bacteria and other microbes in the urine and gut of patients. Researchers will collect urine and stool samples from participants to see if changes in these microbes can be linked to how well patients recover from the side effects of radiation, particularly in areas like the bladder and bowel that may be affected during treatment. The goal is to find out if the microbiome plays a role in healing and if it could help improve the quality of life for men undergoing treatment for prostate cancer.

To be eligible for this study, participants must be men aged 18 or older with confirmed prostate cancer who plan to receive radiation therapy. There are specific groups within the study based on the type of radiation therapy they will receive, and participants will need to provide urine and stool samples at different times during their treatment. It’s important to note that men with certain bowel conditions or bladder inflammation will not be able to participate. This research could help identify new factors that influence recovery and offer ways to enhance the care provided to prostate cancer patients.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Men with inflammatory bowel disease or pre-existing cystitis will be excluded