Actively Recruiting

Age: 18Years +
MALE
NCT04775355

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

Led by City of Hope Medical Center · Updated on 2025-09-16

30

Participants Needed

1

Research Sites

276 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed prostate cancer with planned radiation therapy for definitive or salvage treatment or radiation without androgen deprivation therapy
  • Cohort A: Gleason grade group 3 or higher with planned androgen deprivation therapy
  • Cohort B: rising prostate-specific antigen and planned androgen deprivation therapy with salvage radiation
  • Cohort C: radiation planned without androgen deprivation therapy
  • Male patients aged 18 years or older
  • Willing to provide urine and stool samples at specified times
Not Eligible

You will not qualify if you...

  • Men with inflammatory bowel disease
  • Men with pre-existing cystitis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

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Research Team

T

Tanya B Dorff

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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