Prospective Prostate Cancer Infrastructure (ProPCI)
28. dubna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Typ studie
Pozorovací
Zápis (Odhadovaný)
700
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
N/A
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Treatment patterns
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Dynamic change in ctDNA fraction
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. května 2026
Primární dokončení (Odhadovaný)
1. května 2030
Dokončení studie (Odhadovaný)
1. května 2030
Termíny zápisu do studia
První předloženo
16. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
28. dubna 2026
První zveřejněno (Aktuální)
1. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. dubna 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2025-18407
- NL-OMON58526 (Identifikátor registru: OMON)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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