Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Prospective Prostate Cancer Infrastructure (ProPCI)

4. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

700

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Niven Mehra, PhD
Telefonnummer: +3124 361 88 00
E-post: niven.mehra@radboudumc.nl

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Treatment patterns Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Dynamic change in ctDNA fraction Tidsramme: 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 Tidsramme: 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) Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Radboud University Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2026

Primær fullføring (Antatt)

1. september 2030

Studiet fullført (Antatt)

1. september 2030

Datoer for studieregistrering

Først innsendt

16. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2026

Sist bekreftet