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

NCT04775355 | Recruiting

• 3 other identifiers: 19382NCI-2021-00700P30CA033572
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of detecting and categorizing urinary and gut microbiota

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

  Up to 3 years

Secondary Outcomes (2)

• Detectability of changes

  Up to 3 years

• Detectability of associations between microbial populations and toxicity

  Up to 3 years

Other Outcomes (1)

• Changes in microbiome

  Baseline up to 3 years after radiation completion

Study Arms (1)

Observational (biospecimen collection, questionnaire)

Patients undergo collection of stool and urine samples within 2 weeks before hormone therapy or radiation therapy, after hormone therapy but before start of radiation therapy, and after completion of radiation therapy. Patients also complete a series of questionnaires prior to starting radiation therapy, mid-way through radiation therapy, and after completion of radiation therapy (within 1-3 weeks, at 3 months, and then every 6 months until 3 years from radiation completion). Patients' medical records are also reviewed.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of stool and urine

Observational (biospecimen collection, questionnaire)

Electronic Health Record Review OTHER

Medical records are reviewed

Observational (biospecimen collection, questionnaire)

Quality-of-Life Assessment OTHER

Complete quality of life questionnaires

Also known as: Quality of Life Assessment

Observational (biospecimen collection, questionnaire)

Questionnaire Administration OTHER

Complete questionnaires

Observational (biospecimen collection, questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with prostate cancer who are receiving definitive or salvage radiation.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool, urine

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tanya B Dorff

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanya B Dorff

CONTACT

626-359-8111; tdorff@coh.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: April 14, 2021
• Primary Completion (Estimated): July 29, 2026
• Study Completion (Estimated): July 29, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)