Observational Study on Microbiome Changes During Prostate Cancer Treatment

This study is looking at how the bacteria, fungi, and viruses (your microbiome) in your gut and urine change during prostate cancer treatment. Specifically, it focuses on patients receiving androgen deprivation therapy (hormone therapy) and radiation therapy for Stage I, II, or III prostate cancer. Researchers want to see if these microbiome changes might affect how your body heals after radiation, which can sometimes cause issues in the bladder or bowel. You would provide urine and stool samples and complete questionnaires about your quality of life. The main goal is to see if it's possible to track these microbiome changes, and a secondary goal is to explore if your microbiome at the start of treatment is linked to any side effects you might experience.

Study design
This is an observational study, meaning no new treatments are given. It plans to enroll 30 men with prostate cancer.
What's involved
You would provide stool and urine samples at different times before, during, and after your treatment. You will also complete questionnaires and your medical records will be reviewed.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for up to 3 years after completing radiation therapy.

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NCT04775355

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

Recruiting
Not specifiedAges 18+Observational
City of Hope Medical Center
~30 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Biospecimen CollectionElectronic Health Record ReviewQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of detecting and categorizing urinary and gut microbiota
Measured over Up to 3 years
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
1 sites across 1 states
California1
  • Tanya B Dorff · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Men with inflammatory bowel disease or pre-existing cystitis will be excluded
  • Feasibility of detecting and categorizing urinary and gut microbiotaUp to 3 years

    Will be defined as the ability to generate a microbial profile for \>= 80% of samples.