Detecting changes in gut and urinary microbiome during prostate cancer treatment
Pilot Study to Describe Changes in Urinary and Gut Microbiome During Androgen Deprivation and Radiation Therapy for Prostate Cancer
City of Hope Medical Center · NCT04775355
This study is trying to see how treatment for prostate cancer affects the bacteria in the gut and urine of patients to understand if these changes relate to side effects from the therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | City of Hope Medical Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT04775355 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult men aged 18 or older with pathologically confirmed prostate cancer who are scheduled to receive radiation therapy, particularly those requiring androgen deprivation therapy.
Not a fit: Patients with inflammatory bowel disease or pre-existing cystitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for prostate cancer patients, enhancing their quality of life during treatment.
How similar studies have performed: While this approach is novel in the context of prostate cancer treatment, similar studies have shown promising results in other cancer types regarding microbiome changes and treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Duarte, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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