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

Stage IV Prostate Cancer AJCC v7 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775355
• Other study ID #: 19382
• Secondary ID: NCI-2021-0070019
• Status: Recruiting
• Start date: April 14, 2021
• Est. completion date: July 29, 2025

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: Tanya B Dorff
• Phone: 626-359-8111
• Email: tdorff[@]coh.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 29, 2025
• Est. primary completion date: July 29, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage I Prostate Cancer AJCC v7
• Stage II Prostate Cancer AJCC v7
• Stage IIA Prostate Cancer AJCC v7
• Stage IIB Prostate Cancer AJCC v7
• Stage III Prostate Cancer AJCC v7
• Stage IV Prostate Cancer AJCC v7

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of stool and urine

Other:
• Electronic Health Record Review
Medical records are reviewed
• Quality-of-Life Assessment
Complete quality of life questionnaires
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Detectability of changes		Up to 3 years
Secondary	Detectability of associations between microbial populations and toxicity		Up to 3 years