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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "OUTLINE: 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects urine and stool samples from people with prostate cancer getting radiation, with or without hormone treatment that lowers male hormones. It looks for changes in the microbiome—the bacteria, fungi, and viruses in the gut and urine—and whether they may help organs heal after radiation.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have prostate cancer confirmed by a tissue test and plan to get radiation treatment.
  • For Group A: Plan to get radiation as the main treatment and have a cancer grade group of 3 or higher, which shows how abnormal the cancer cells look.
  • For Group B: Have a rising PSA level—a blood marker for prostate cancer—and plan to get hormone treatment with radiation after earlier treatment.
  • For Group C: Plan to get radiation as the main treatment or after earlier treatment, without hormone treatment.
  • Be willing to give urine and stool samples at set times.

Who can't join

  • Have inflammatory bowel disease, which causes long-term swelling in the gut.
  • Already have cystitis, which is swelling or irritation of the bladder.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

CA