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

Recruiting now

Conditions studied: Stage I Prostate Cancer AJCC v7, Stage II Prostate Cancer AJCC v7, Stage IIA Prostate Cancer AJCC v7, Stage IIB Prostate Cancer AJCC v7, Stage III Prostate Cancer AJCC v7, Stage IV Prostate Cancer AJCC v7

In brief

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 cancer during androgen deprivation therapy and radiation therapy. Radiation therapy has the potential to harm the genitourinary area or the bowel, causing a feeling of urgency or increased inflammation in the area. The radiation therapy is designed to not irradiate the bowel and bladder areas, but there is still some radiation exposure. The gut microbiome has been associated with differences in inflammation as well as producing molecules that influence healing. The purpose of this study is to see whether the microbiome may contribute to the healing of the organs exposed to radiation. Information learned from this study may help researchers discover a new risk factor that could be manipulated to improve the quality of life in patients with prostate cancer.

Key facts

Study ID

NCT04775355

Run by

City of Hope Medical Center

People needed

30

Starts

2021-04-14

Expected to finish

2026-07-29

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• City of Hope Medical Center — Duarte, California, United States (enrolling)

Full record on ClinicalTrials.gov

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