Detecting changes in gut and urinary microbiome during prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect urine and stool samples from patients with prostate cancer undergoing androgen deprivation therapy and radiation therapy to identify changes in their microbiomes. The study will assess the feasibility of linking these microbiome changes to urinary and gastrointestinal radiation toxicity. Patients will provide samples at various time points and complete questionnaires to evaluate their quality of life and any adverse effects experienced during treatment. The findings may reveal new risk factors that could be targeted to enhance patient recovery and quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Men with inflammatory bowel disease or pre-existing cystitis will be excluded

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Tanya B Dorff — City of Hope Medical Center
• Study coordinator: Tanya B Dorff
• Email: tdorff@coh.org
• Phone: 626-359-8111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.