Prospective Prostate Cancer Infrastructure (ProPCI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: High Risk Localized Prostate Cancer; Synchronous Metastatic Hormone-Sensitive Prostate Cancer

• Study Type: Observational
• Enrollment (Estimated): 700

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment patterns	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	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	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	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	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	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	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)	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	Time from diagnosis to death from any cause.	From diagnosis through study completion, up to 4 years
Adverse events	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	Total number of planned and unplanned hospital admissions.	From treatment initiation through study completion, up to 4 years
Number of outpatient visits	Total number of outpatient visits	From treatment initiation through study completion, up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic change in ctDNA fraction	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	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)	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)	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	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	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	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.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-18407; NL-OMON58526 (Registry Identifier: OMON)