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Идёт набор NCT05129605

Prostate Cancer Genetic Risk Evaluation and Screening Study

— Наблюдательное Prostatic Neoplasm Prostate Cancer BRCA2 Mutation BRCA1 Mutation

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: Prostate cancer screening.
Кому может быть актуально
Состояния в реестре: Prostatic Neoplasm, Prostate Cancer, BRCA2 Mutation, BRCA1 Mutation. Базовые параметры: 35 лет — 74 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)

Обзор

This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.

Подробное описание

Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men. Prostate cancer has substantial inherited predisposition and men harboring specific genetic variants or a positive family history have been associated with an increased risk of developing prostate cancer. Men with specific genetic variants, such as pathogenic BRCA2 mutations, are at particularly greater risk of developing aggressive forms of prostate cancer and thus warrant undergoing careful screening for prostate cancer. However, the penetrance of many mutations in prostate cancer risk genes is unknown, and some men have no identifiable mutations in known risk genes despite a strong family history of prostate cancer. Prospectively collected clinical data along with biospecimens from unaffected individuals at high genetic risk for developing prostate cancer will advance the understanding of how specific mutations contribute to the development of prostate cancer and how these prostate cancers might be best detected. The purpose of this study is to prospectively screen men at high risk genetic risk for prostate cancer by prostate exam, PSA, and prostate MRI to characterize the penetrance and cancer-related outcomes of specific mutations, identify potentially novel genetic risk mutations and/or markers for early detection.

Вмешательства

  • Диагностический тест Prostate cancer screening
    Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate

Первичные конечные точки

  • Diagnosis of prostate cancer [Срок оценки: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first]
Вторичные конечные точки (1)
  • Positive predictive value of multiparametric MRI for detection of prostate cancer [Срок оценки: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first]

Критерии участия

Критерии включения

  • Men 35-74 years old
  • No known diagnosis of prostate cancer
  • Life expectancy >10 years
  • Meet cohort A, B, or C criteria
  • Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
  • Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
  • Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry

Критерии исключения

  • Prior diagnosis or treatment of prostate cancer
  • Inability to undergo prostate MRI
  • Inability to receive MRI contrast agent

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
  • Massachusetts General Hospital — Boston

Публикации

  • Amini AE, Salari K. Incorporating Genetic Risk Into Prostate Cancer Care: Implications for Early Detection and Precision Oncology. JCO Precis Oncol. 2024 Feb;8:e2300560. doi: 10.1200/PO.23.00560. PMID 38412389
  • Amini AE, Hunter AE, Almashad A, Feng AJ, Patel ND, O'Dea MR, McCormick SR, Rodgers LH, Salari K. Magnetic Resonance Imaging-based Prostate Cancer Screening in Carriers of Pathogenic Germline Mutations: Interim Results from the Initial Screening Round of the Prostate Cancer Genetic Risk Evaluation and Screening Study. Eur Urol Oncol. 2024 Dec;7(6):1358-1366. doi: 10.1016/j.euo.2024.01.015. Epub 20 PMID 38453598

Идентификаторы

NCT: NCT05129605 · 2020P000081

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗