Prospective Prostate Cancer Infrastructure (ProPCI)
28 kwietnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Typ studiów
Obserwacyjny
Zapisy (Szacowany)
700
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie dotyczy
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
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.
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Treatment patterns
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Dynamic change in ctDNA fraction
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 maja 2026
Zakończenie podstawowe (Szacowany)
1 maja 2030
Ukończenie studiów (Szacowany)
1 maja 2030
Daty rejestracji na studia
Pierwszy przesłany
16 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
28 kwietnia 2026
Pierwszy wysłany (Rzeczywisty)
1 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
1 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 kwietnia 2026
Ostatnia weryfikacja
1 kwietnia 2026
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 2025-18407
- NL-OMON58526 (Identyfikator rejestru: OMON)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .