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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT04775355
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Apr 14, 2021
Status verified
Sep 2025
Primary completion
Jul 29, 2026
Completion
Jul 29, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Observational (biospecimen collection, questionnaire)
    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.

Primary Outcome Measure

Feasibility of detecting and categorizing urinary and gut microbiota [ Time Frame: Up to 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Tanya B. Dorff
626-256-4673
Tanya B. Dorff (PRINCIPAL_INVESTIGATOR)

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City of Hope Medical Center· Duarte, CA

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