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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage IV Prostate Cancer AJCC v7; Stage IIA Prostate Cancer AJCC v7; Stage III Prostate Cancer AJCC v7; Stage I Prostate Cancer AJCC v7; Stage IIB Prostate Cancer AJCC v7; Stage II Prostate Cancer AJCC v7
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Electronic Health Record Review; Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the feasibility of identifying changes in urine and gut microbiomes during androgen deprivation therapy and radiation therapy for prostate cancer.

SECONDARY OBJECTIVE:

I. 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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Tanya B Dorff; Phone Number: 626-359-8111; Email: tdorff@coh.org

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Tanya B. Dorff; Phone Number: 89200 626-256-4673
      • Principal Investigator: Tanya B. Dorff

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with prostate cancer who are receiving definitive or salvage radiation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

Other: Quality-of-Life Assessment; Complete quality of life questionnaires; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Complete questionnaires; Other: Electronic Health Record Review; Medical records are reviewed; Procedure: Biospecimen Collection; Undergo collection of stool and urine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of detecting and categorizing urinary and gut microbiota	Will be defined as the ability to generate a microbial profile for >= 80% of samples.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Detectability of changes	Up to 3 years
Detectability of associations between microbial populations and toxicity	Up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in microbiome	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.	Baseline up to 3 years after radiation completion

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tanya B Dorff, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Estimated): December 28, 2023
• Study Completion (Estimated): December 28, 2023

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 19382 (Other Identifier: City of Hope Comprehensive Cancer Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2021-00700 (Registry Identifier: CTRP (Clinical Trial Reporting Program))