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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Suspended
CT.gov ID
NCT04775355
Collaborator
National Cancer Institute (NCI) (NIH)
30
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Electronic Health Record Review
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. To determine the feasibility of identifying changes in urine and gut microbiomes during androgen deprivation therapy and radiation therapy for prostate cancer.
SECONDARY OBJECTIVE:
  1. To explore associations between baseline microbiomes and urinary or gastrointestinal radiation toxicity by Common Terminology Criteria for Adverse Events (CTCAE) and Patient Reported Outcomes (PRO).
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. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pilot Study to Describe Changes in Urinary and Gut Microbiome During Androgen Deprivation and Radiation Therapy for Prostate Cancer
Actual Study Start Date :
Apr 14, 2021
Anticipated Primary Completion Date :
Mar 28, 2023
Anticipated Study Completion Date :
Mar 28, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Undergo collection of stool and urine

Other: Electronic Health Record Review
Medical records are reviewed

Other: Quality-of-Life Assessment
Complete quality of life questionnaires
Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Complete questionnaires

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of detecting and categorizing urinary and gut microbiota [Up to 3 years]

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

    Secondary Outcome Measures

    1. Detectability of changes [Up to 3 years]

    2. Detectability of associations between microbial populations and toxicity [Up to 3 years]

    Other Outcome Measures

    1. Changes in microbiome [Baseline up to 3 years after radiation completion]

      The baseline microbiome and changes in microbiome will be evaluated for association with acute and late toxicity (graded by Common Terminology Criteria for Adverse Events) and patient reported outcomes (Functional Assessment of Cancer Therapy - Prostate [FACT-P], International Index of Erectile Function). Changes in FACT-P scores over time will be summarized as point changes (absolute value) from baseline for the first post-treatment time point and from the previous time point for all other time points. Changes in the microbiome will also be placed in context by obtaining dietary information to determine any patterns of diet which may confound or influence the changes in microbiome identified in the primary analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Tanya B Dorff, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT04775355
    Other Study ID Numbers:
    • 19382
    • NCI-2021-00700
    • 19382
    • P30CA033572
    First Posted:
    Mar 1, 2021
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2022