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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorCity of Hope Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Electronic Health Record Review
  • Quality-of-Life Assessment
  • Questionnaire Administration

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator