Predicción del cáncer de próstata en hombres mayores
Predicción del cáncer de próstata utilizando un panel de biomarcadores de plasma y orina combinados en un algoritmo en hombres mayores de 70 años
We aim to analyze whether the "liquid biopsy" model could increase the specificity of detecting men with an aggressive (defined as Gleason score ≥ 7) prostate cancer and thereby reduce the proportion of men who undergo prostate biopsy, while at the same time maintaining the same sensitivity to detect aggressive prostate cancer as the PSA test alone. Using blood and urine biomarkers together with an algorithm, which incorporates the clinical data, we aim to identify patients who have a high risk of having an aggressive prostate cancer. By performing this non-invasive test we expect that we can reduce need for prostate biopsy and reduce the detection of patients with an indolent prostate cancer (defined by Gleason score ≤ 6). Thereby we aim to reduce the side effects of transrectal ultrasound guided biopsy of the prostate and side-effects of living with an indolent cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
BACKGROUND Prostate biopsy is currently the standard of care for prostate cancer diagnosis, oftentimes reflexed after the detection of an elevated serum prostate-specific antigen (PSA). Unfortunately, prostate biopsy is not without potential complications, which include discomfort, pain, bleeding, and infections ranging from cystitis to septic sepsis and even death. Bleeding has been reported in 6-13% of patients undergoing prostate biopsy, while 0.3-4% experience admission with sepsis. Furthermore, some newly diagnosed prostate cancers are indolent while other may be more aggressive with metastatic potential, with resultant risk of death. A PSA level ≥4.0 ng/ml is frequently used as a threshold warranting a biopsy evaluation. Elevated PSA level may reflect benign prostatic hyperplasia (BPH), inflammation, or malignancy. Some series suggest that only 20-30% of patients with PSA 4 - 10 ng/ml, have prostate cancer, resulting in a high number of patients undergoing an unnecessary biopsy. We recently reported the ability of "Liquid Biopsy" to predict the presence of aggressive prostate cancer using a combination of biomarkers detected in urine and peripheral blood plasma. Concluding that "Liquid Biopsy" can predict the presence of aggressive prostate cancer (GS ≥7).
AIM With this study we want of compare "Liquid Biopsy", defined by our blood and urine panel against prostate biopsy in a large-scale randomized manner including men referred for a biopsy due to the suspicion of prostate cancer over the age of 70 (elderly).
OBJECTIVE The primary objectives of this study are to test the ability of the "liquid biopsy" to
- Detect as many patients with aggressive prostate cancer as the standard method (PSA).
- Reduce the number of prostate biopsy sets taken and thereby reduce the number of patients detected with indolent prostate cancer.
The secondary objectives are to evaluate
- The economic effect of implementation of the test with regard to reduced biopsies taken, iatrogenic infectious disease and reduced control of indolent prostate cancer.
- The association of the liquid biopsy to tumor grade and tumor volume in biopsied men.
- The Quality of life.
- Progression and survival: overall survival, prostate cancer specific survival, PSA recurrence, time to metastases, time to castration resistance
- Safety
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Odense, Dinamarca, 5000
- Department of Urology, Odense University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Suspicion of prostate cancer due to elevated PSA, and/or palpable tumor in the prostate
- Indication for digital rectal examination and trans-rectal ultrasound with biopsy
- Age: 70 years or above
- PSA: 20 or above
- Able to provide informed written consent (competent adults only)
Exclusion Criteria:
- Previously diagnosed with prostate cancer
- Receiving treatment influencing PSA levels
- Medical conditions that may interfere with the study such as previously cancer-related therapy
- Life expectancy of less than 10 years
- MRI of the prostate within the last 2 years
- Digital rectal examination of the prostate within 24 hours or ejaculation within 24 hours
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Liquid Biopsy
Experimental arm where the "liquid biopsy" decides whether to perform an prostate biopsy or not |
Measuring biomarkers in blood and urine samples |
|
Otro: Standard Biopsy
Standard arm, where every patient receives a standard prostate biopsy |
Histological examination of tissue biopsies |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Test sensitivity
Periodo de tiempo: 2 years
|
Number of detected patients with aggressive prostate cancer, defined as Gleason score ≥ 7. |
2 years
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Test specificity
Periodo de tiempo: 20 years
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Number of patients who had prostate biopsies |
20 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Lars Lund, MD, DMSci, Odense University Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Procesos Patológicos
- Neoplasias Genitales Masculinas
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades Genitales Masculinas
- Enfermedades prostáticas
- Enfermedades urogenitales masculinas
- Condiciones Patológicas, Signos y Síntomas
- Neoplasias prostáticas
- Enfermedad
- Técnicas de investigación
- Manejo de muestras
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Técnicas citológicas
- Biopsia
- Citodiagnóstico
- Biopsia líquida
Otros números de identificación del estudio
- DaProCa4
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Personal data is maintained in a safe database with logging and only anonymized data will be shared if needed.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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