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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-00700 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19382 | Other Identifier | City of Hope Comprehensive Cancer Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of stool and urine |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Detectability of changes | Up to 3 years | |
| Detectability of associations between microbial populations and toxicity | Up to 3 years |
| 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. |
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
Patients must be age 18 or older
Willing to provide urine and stool samples at specified time points
Exclusion Criteria:
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Patients with prostate cancer who are receiving definitive or salvage radiation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tanya B Dorff | Contact | 626-359-8111 | tdorff@coh.org |
| Name | Affiliation | Role |
|---|---|---|
| Tanya B Dorff | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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Stool, urine
| Electronic Health Record Review | Other | Medical records are reviewed |
|
| Quality-of-Life Assessment | Other | Complete quality of life questionnaires |
|
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| Questionnaire Administration | Other | Complete questionnaires |
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| Baseline up to 3 years after radiation completion |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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