NCT04775355

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

Pilot Study to Describe Changes in Urinary and Gut Microbiome During Androgen Deprivation and Radiation Therapy for Prostate Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 OBJECTIVE: I. To explore associations between baseline microbiomes and urinary or gastrointestinal radiation toxicity by Common Terminology Criteria for Adverse Events (CTCAE) and Patient Reported Outcomes (PRO). OUTLINE: Patients undergo collection of stool and urine samples within 2 weeks before hormone therapy or radiation therapy, after hormone therapy but before start of radiation therapy, and after completion of radiation therapy. Patients also complete a series of questionnaires prior to starting radiation therapy, mid-way through radiation therapy, and after completion of radiation therapy (within 1-3 weeks, at 3 months, and then every 6 months until 3 years from radiation completion). Patients' medical records are also reviewed.

Conditions

• 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

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of stool and urine
OTHER	Electronic Health Record Review	Medical records are reviewed
OTHER	Quality-of-Life Assessment	Complete quality of life questionnaires
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2021-04-14
• Primary completion: 2026-07-29
• Completion: 2026-07-29
• First posted: 2021-03-01
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States