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Prospective Prostate Cancer Infrastructure (ProPCI)

4 de setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

700

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Niven Mehra, PhD
Número de telefone: +3124 361 88 00
E-mail: niven.mehra@radboudumc.nl

Locais de estudo

Holanda
- - Nijmegen, Holanda
    - Recrutamento
    - Radboud University Medical Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

N/D

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Treatment patterns Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 resultados secundários

Medida de resultado	Descrição da medida	Prazo
Dynamic change in ctDNA fraction Prazo: 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 Prazo: 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) Prazo: 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) Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Radboud University Medical Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2030

Conclusão do estudo (Estimado)

1 de setembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

16 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de abril de 2026

Primeira postagem (Real)

1 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de setembro de 2026

Última verificação