Recruiting

Observational Study

Sponsor:

City of Hope Medical Center

Code:

NCT04775355

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

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Electronic Health Record Review

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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

Study ID

NCT04775355

Start date

Apr 14, 2021

Status verified date

Aug, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo collection of stool and urine

Electronic Health Record Review

Medical records are reviewed

Quality-of-Life Assessment

Complete quality of life questionnaires

Questionnaire Administration

Complete questionnaires

Primary outcome measure

  • Feasibility of detecting and categorizing urinary and gut microbiota [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Tanya B. Dorff

626-256-4673

Principal Investigator:

Tanya B. Dorff

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-19.