Prospective Prostate Cancer Infrastructure (ProPCI)
28. April 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
700
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
N/A
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Treatment patterns
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Dynamic change in ctDNA fraction
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Mai 2026
Primärer Abschluss (Geschätzt)
1. Mai 2030
Studienabschluss (Geschätzt)
1. Mai 2030
Studienanmeldedaten
Zuerst eingereicht
16. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. April 2026
Zuerst gepostet (Tatsächlich)
1. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 2025-18407
- NL-OMON58526 (Registrierungskennung: OMON)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .