Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIA Prostate Cancer AJCC v7 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer AJCC v7 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Prostate Cancer AJCC v7 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Prostate Cancer AJCC v7 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer AJCC v7 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer AJCC v7 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (biospecimen collection, questionnaire)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Feasibility of detecting and categorizing urinary and gut microbiota
- timeFrame
- Up to 3 years
- description
- Will be defined as the ability to generate a microbial profile for \>= 80% of samples.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available