RecruitingNCT04775355

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


Sponsor

City of Hope Medical Center

Enrollment

30 participants

Start Date

Apr 14, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study examines how the bacteria living in the urine and gut (called the microbiome) change in men with prostate cancer who are receiving radiation therapy — with or without hormone-suppressing therapy (androgen deprivation therapy, or ADT). Understanding these changes could help reduce treatment side effects. **You may be eligible if...** - You have prostate cancer confirmed by biopsy - You are planning to receive radiation therapy, either as a primary treatment or to treat a rising PSA after prior treatment - You are 18 or older - You are willing to provide urine and stool samples at specific time points **You may NOT be eligible if...** - You have inflammatory bowel disease - You have taken antibiotics recently or are on long-term antibiotic therapy - You are unwilling to provide biological samples Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of stool and urine

OTHERElectronic Health Record Review

Medical records are reviewed

OTHERQuality-of-Life Assessment

Complete quality of life questionnaires

OTHERQuestionnaire Administration

Complete questionnaires


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT04775355


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