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Prospective Prostate Cancer Infrastructure (ProPCI)

4 de septiembre de 2026 actualizado por: Radboud University Medical Center
The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer. This will help to better understand how these patients are treated in daily practice, how treatments affect quality of life, and facilitate biomarker discovery. The infrastructure is also designed to enable future cohort multiple randomized controlled trials.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Tipo de estudio

De observación

Inscripción (Estimado)

700

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Países Bajos
      • Nijmegen, Países Bajos
        • Reclutamiento
        • Radboud University Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

All patients with treatment-naive high-risk localized and treatment-naive metastatic prostate carcinoma will be eligible to participate. These patients are identified by their treating physicians in all participating hospitals.

Descripción

Inclusion Criteria:

  • Diagnosis of either: high-risk localized prostate cancer (any of the following: PSA > 20 ng/mL, ISUP Grade Group 4 or 5, or clinical stage ≥ T2c); or metastatic prostate cancer confirmed by imaging (CT, bone scintigraphy, PSMA PET/CT, or (whole-body) MRI in combination with tumor markers (PSA)), or by biopsy of a metastatic lesion histopathologically deemed to be of prostatic origin.
  • Prostate adenocarcinoma (our main focus). We will allow the inclusion of adenocarcinoma with mixed small- or large-cell neuroendocrine prostate
  • Age ≥ 18 years at the time of inclusion.
  • Written informed consent
  • Able to understand one of the following languages sufficiently: Dutch, English, Arabic or Turkish.

Exclusion Criteria:

  • Not currently living in the Netherlands.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Treatment patterns
Periodo de tiempo: From diagnosis through study completion, up to 4 years
Documentation of initial and sequential treatment strategies, including type, timing, and combination of androgen deprivation therapy, androgen receptor pathway inhibitors, chemotherapy, and radiotherapy, within 4 months and beyond 4 months after diagnosis.
From diagnosis through study completion, up to 4 years
PSA response
Periodo de tiempo: From treatment initiation up to 12 months.
Proportion of patients achieving >50% and >90% PSA decline from baseline within the first year after treatment initiation.
From treatment initiation up to 12 months.
PSA nadir
Periodo de tiempo: From treatment initiation up to 12 months
Lowest PSA value achieved within 1 year after treatment initiation and time from treatment initiation to PSA nadir.
From treatment initiation up to 12 months
Utilization of imaging modalities for primary staging
Periodo de tiempo: At baseline
Type and frequency of imaging modalities used at primary staging, including PSMA PET/CT, conventional CT, bone scintigraphy, and MRI.
At baseline
Time to clinical progression
Periodo de tiempo: From treatment initiation through study completion, up to 4 years
Time from treatment initiation to clinical progression, defined as local progression, and/or symptomatic skeletal events (pain, fracture, spinal cord compression), or initiation of surgery or radiotherapy for progression.
From treatment initiation through study completion, up to 4 years
Time to biochemical progression
Periodo de tiempo: From treatment initiation through study completion, up to 4 years
Time from treatment initiation to biochemical progression per PCWG3 criteria, defined as a minimum PSA rise of 25% AND an absolute increase of 2ng/mL from the nadir, confirmed on two measurements ≥3 weeks apart.
From treatment initiation through study completion, up to 4 years
Time to radiographic progression
Periodo de tiempo: From treatment initiation through study completion, up to 4 years
Time from treatment initiation to radiographic progression based on imaging (conventional imaging, PSMA PET/CT), or RECIST 1.1 criteria.
From treatment initiation through study completion, up to 4 years
Time to castration-resistant prostate cancer (CRPC)
Periodo de tiempo: From treatment initiation through study completion, up to 4 years
Time from treatment initiation to castration-resistant prostate cancer (CRPC) per PCWG3 criteria.
From treatment initiation through study completion, up to 4 years
Overall survival
Periodo de tiempo: From diagnosis through study completion, up to 4 years
Time from diagnosis to death from any cause.
From diagnosis through study completion, up to 4 years
Adverse events
Periodo de tiempo: From treatment initiation through study completion, up to 4 years
Type, grade, and treatment-relatedness of adverse events occurring during treatment, graded according to the Common Terminology Criteria for Adverse Events version 5.0.
From treatment initiation through study completion, up to 4 years
Number of hospital admissions
Periodo de tiempo: From treatment initiation through study completion, up to 4 years
Total number of planned and unplanned hospital admissions.
From treatment initiation through study completion, up to 4 years
Number of outpatient visits
Periodo de tiempo: From treatment initiation through study completion, up to 4 years
Total number of outpatient visits
From treatment initiation through study completion, up to 4 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dynamic change in ctDNA fraction
Periodo de tiempo: Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.
Change in ctDNA fraction at 4-6 weeks and 9 months after start of initial treatment.
Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.
Prevalence and clinical phenotypes of genomic alterations
Periodo de tiempo: At diagnosis or at disease progression, up to 4 years
Prevalence and clinical phenotype associations of somatic alterations in prostate cancer related genes and (likely) pathogenic germline variants, detected by cfDNA or tumor tissue.
At diagnosis or at disease progression, up to 4 years
Health-Related Quality of Life (Global Health Status)
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Clinically meaningful change in Global Health Status using the EORTC QLQ-C30 as a measure for Health Related Quality of Life, from baseline to sequential follow-up.
Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Health-Related Quality of Life (Health Utility)
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months
Change in health utility index and EQ Visual Analogue Scale score measured using the EQ-5D-5L, across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months
Pain intensity and interference
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Change in average pain score and pain interference score measured using the Brief Pain Inventory - Short Form (BPI-SF).
Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Fatigue severity and interference
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Change in average fatigue score and fatigue interference score measured using the Brief Fatigue Inventory (BFI).
Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Prostate cancer-specific symptoms
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Change in prostate cancer-specific symptoms measured using the EORTC QLQ-PR25, domain scores for urinary symptoms, bowel symptoms, hormonal treatment-related symptoms, sexual activity, and sexual functioning.
Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Radboud University Medical Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2030

Finalización del estudio (Estimado)

1 de septiembre de 2030

Fechas de registro del estudio

Enviado por primera vez

16 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de abril de 2026

Publicado por primera vez (Actual)

1 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2025-18407
  • 2025 (Subvención/contrato del NIH de EE. UU.: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • NL-OMON58526 (Identificador de registro: OMON)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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