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

NCT04775355 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-09-16

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Tanya B Dorff · City of Hope Medical Center

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2026-07-29
Completion
2026-07-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04775355 on ClinicalTrials.gov