Prospective Prostate Cancer Infrastructure (ProPCI)
28 aprile 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
700
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
N/A
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Treatment patterns
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dynamic change in ctDNA fraction
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 maggio 2026
Completamento primario (Stimato)
1 maggio 2030
Completamento dello studio (Stimato)
1 maggio 2030
Date di iscrizione allo studio
Primo inviato
16 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 aprile 2026
Primo Inserito (Effettivo)
1 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2025-18407
- NL-OMON58526 (Identificatore di registro: OMON)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .