ProPCI

Prospective Prostate Cancer Infrastructure - ProPCI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON58526

Enrollment

700

Registered

2026-04-07

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High risk localized prostate cancer, synchronous metastatic hormone-sensitive prostate cancer Aggressive prostate cancer, metastatic prostate cancer

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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   cancer, and for pure small- or large cell neuroendocrine prostate cancer.   ? 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

Exclusion criteria: Not currently living in the Netherlands.

Design outcomes

Primary

Measure	Time frame
ProPCI captures multiple outcome domains. Clinical outcomes include real-world treatment patterns, PSA kinetics, time to castration-resistant prostate cancer, radiographic and clinical progression, overall survival, and adverse events. Biomarker outcomes include ctDNA fraction dynamics and somatic and germline alterations with associated clinical phenotypes. Health-related quality-of-life trajectories and healthcare utilization including hospital admissions, outpatient visits, and treatment-related costs are additional outcome domains.	—

Measure

Time frame

ProPCI captures multiple outcome domains. Clinical outcomes include real-world treatment patterns, PSA kinetics, time to castration-resistant prostate cancer, radiographic and clinical progression, overall survival, and adverse events. Biomarker outcomes include ctDNA fraction dynamics and somatic and germline alterations with associated clinical phenotypes. Health-related quality-of-life trajectories and healthcare utilization including hospital admissions, outpatient visits, and treatment-related costs are additional outcome domains.

—

Secondary

Measure	Time frame
Specific secondary endpoints will be defined within the statistical analysis plans for individual studies or cmRCTs embedded within the ProPCI infrastructure.	—

Countries

Netherlands

Contacts

Public ContactR.O. Wissing

Radboud Universitair Medisch Centrum

ruben.wissing@radboudumc.nl0243618800

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 23, 2026