Prostate Cancer Genetic Risk Evaluation and Screening Study
Prostatic Neoplasm · Prostate Cancer · BRCA2 Mutation · BRCA1 Mutation · ATM Gene Mutation · MMR Mutation · Lynch Syndrome · Genetic Predisposition to Disease
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 35 años - No especificado
- Sexo admitido
- Masculino
- Voluntarios sanos
- No aceptados
- Participantes
- 400 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Individuals with a prostate aged 35 years or older
- 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
Exclusion Criteria:
- Prior diagnosis or treatment of prostate cancer
- Inability to undergo prostate MRI
- Inability to receive MRI contrast agent
Población del estudio
Individuals aged 35 years or older at high genetic risk for prostate cancer on the basis of a specific germline genetic mutation or a strong family history.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Cohort A
Documented germline known pathogenic or likely pathogenic mutation in a prostate cancer related risk gene
Diagnostic Test: Prostate cancer screening
Cohort B
Family history suggestive of high genetic risk for prostate cancer with clinical genetic testing negative for known pathogenic or likely pathogenic mutations in prostate cancer-related risk genes
Diagnostic Test: Prostate cancer screening
Cohort C
Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry
Diagnostic Test: Prostate cancer screening
Prostate cancer screening DIAGNOSTIC_TEST
Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Diagnosis of prostate cancer
Plazo: Up to 10 years
Diagnosis of overall and clinically significant (grade group 2 or higher) prostate cancer
Medidas secundarias
Positive predictive value of multiparametric MRI for detection of prostate cancer
Plazo: Up to 10 years
Positive predictive value of multiparametric prostate MRI for detecting clinically significant prostate cancer in men at high genetic risk for prostate cancer with a positive MRI (PI-RADS score of 3 or higher)
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Massachusetts General HospitalBoston, Massachusetts, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Massachusetts General Hospital
- Inicio del estudio
- 12 feb 2020 Real
- Finalización primaria
- 2030-12 Estimado
- Finalización del estudio
- 2040-12 Estimado
- Primera publicación
- 22 nov 2021 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026