NCT04775355Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 25 Feb 2021
- Start date
- 25 Feb 2021
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT04775355
What you commit to
- Study type: Observational
- Planned participants: 30
- From 25 Feb 2021 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Men with inflammatory bowel disease or pre-existing cystitis will be excluded
Who the study is looking for
- Pathologically confirmed prostate cancer, with a plan to receive radiation therapy for either definitive (cohort A) or salvage (cohort B) therapy. Patients without planned androgen deprivation therapy (ADT) will be accrued to cohort C
- Cohort A will be restricted to Gleason grade group 3 or higher (4+3 or 8-10) so that androgen deprivation will be indicated
- Cohort B will not be restricted by Gleason grade but will require rising prostate-specific antigen (PSA) and a plan for ADT with salvage radiation
- Cohort C will be prostate cancer patients in whom definitive or salvage radiation is planned without ADT
- Patients must be age 18 or older
- Willing to provide urine and stool samples at specified time points
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.