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Prospective Prostate Cancer Infrastructure (ProPCI)

4 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

700

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Niven Mehra, PhD
Telefoonnummer: +3124 361 88 00
E-mail: niven.mehra@radboudumc.nl

Studie Locaties

Nederland
- - Nijmegen, Nederland
    - Werving
    - Radboud University Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

NVT

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Treatment patterns Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Dynamic change in ctDNA fraction Tijdsspanne: 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 Tijdsspanne: 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) Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Radboud University Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2030

Studie voltooiing (Geschat)

1 september 2030

Studieregistratiedata

Eerst ingediend

16 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2026

Eerst geplaatst (Werkelijk)

1 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

4 september 2026

Laatst geverifieerd