RecruitingNCT04775355

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

Pilot Study to Describe Changes in Urinary and Gut Microbiome During Androgen Deprivation and Radiation Therapy for Prostate Cancer


Sponsor

City of Hope Medical Center

Enrollment

30 participants

Start Date

Apr 14, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria1

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

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of stool and urine

OTHERElectronic Health Record Review

Medical records are reviewed

OTHERQuality-of-Life Assessment

Complete quality of life questionnaires

OTHERQuestionnaire Administration

Complete questionnaires


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT04775355


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