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Идёт набор NCT04775355

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

— Наблюдательное Stage I Prostate Cancer AJCC v7 Stage II Prostate Cancer AJCC v7 Stage IIA Prostate Cancer AJCC v7 Stage IIB Prostate Cancer AJCC v7

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Biospecimen Collection, Electronic Health Record Review, Quality-of-Life Assessment, Questionnaire Administration.
Кому может быть актуально
Состояния в реестре: Stage I Prostate Cancer AJCC v7, Stage II Prostate Cancer AJCC v7, Stage IIA Prostate Cancer AJCC v7, Stage IIB Prostate Cancer AJCC v7. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура Biospecimen Collection
    Undergo collection of stool and urine
  • Другое Electronic Health Record Review
    Medical records are reviewed
  • Другое Quality-of-Life Assessment
    Complete quality of life questionnaires
  • Другое Questionnaire Administration
    Complete questionnaires

Первичные конечные точки

  • Feasibility of detecting and categorizing urinary and gut microbiota [Срок оценки: Up to 3 years]
Вторичные конечные точки (2)
  • Detectability of changes [Срок оценки: Up to 3 years]
  • Detectability of associations between microbial populations and toxicity [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Men with inflammatory bowel disease or pre-existing cystitis will be excluded

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT04775355 · 19382 · NCI-2021-00700 · 19382 · P30CA033572

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗