ProPCI is a nationwide, multicentre observational cohort study designed to collect comprehensive longitudinal real-world data, biomaterials, and patient-reported outcomes from men with high-risk localised prostate cancer or synchronous metastatic hormone-sensitive prostate cancer in the Netherlands to support evidence generation, biomarker discovery, and future randomised trials.
Key Findings
Methods
The ProPCI study targets two specific patient populations: adult men with high-risk localised prostate cancer or synchronous metastatic hormone-sensitive prostate cancer (mHSPC) across hospitals in the Netherlands.
The study is nationwide and multicentre in design.
Inclusion is limited to adult men with either high-risk localised prostate cancer or synchronous mHSPC.
The study operates across multiple hospitals throughout the Netherlands.
The cohort is described as prospective and observational.
Methods
Clinical data collection in ProPCI relies on extraction from electronic health records using a standardised protocol linked to national registries and healthcare use datasets.
Data extraction follows a standardised protocol to ensure consistency across sites.
Clinical data are linked to national registries.
Healthcare use datasets are also incorporated into the linkage.
This approach is intended to support real-world evidence generation.
Methods
Patient-reported outcome measures (PROMs) are collected at baseline and at regular intervals using validated instruments.
PROMs collection is longitudinal, beginning at baseline.
Validated instruments are used for health-related quality of life assessment.
Participation in quality-of-life questionnaires is listed as an optional consent component.
Health-related quality of life trajectories are listed among the primary outcomes of interest.
Methods
Serial blood samples are biobanked for circulating tumour DNA (ctDNA) and other molecular analyses to facilitate biomarker discovery.
Blood sample collection is serial (repeated over time) rather than one-time.
Samples are specifically intended for circulating tumour DNA analysis.
Collection of additional blood samples and use of biomaterials for genomic testing are optional consent components.
Exploratory biomarker-outcome associations are listed among the study outcomes.
The biobanking infrastructure is designed to support future biomarker discovery.
Methods
The study's primary outcomes include diagnostic and treatment patterns, PSA kinetics, time to castration-resistant prostate cancer, radiological and clinical progression, health-related quality of life trajectories, healthcare use and expenditure, and exploratory biomarker associations.
Prostate-specific antigen (PSA) kinetics are a defined outcome measure.
Time to castration-resistant prostate cancer is a specified endpoint.
Both radiological and clinical progression are tracked as outcomes.
Healthcare expenditure is explicitly included as an outcome, enabling health economic analyses.
Methods
Statistical methods planned for the study include descriptive analyses, time-to-event models, mixed-effects models, and biomarker-outcome correlates.
Time-to-event models will be used for endpoints such as time to castration-resistant prostate cancer and progression.
Mixed-effects models are planned for longitudinal outcomes such as quality-of-life trajectories.
Biomarker-outcome correlations are described as exploratory analyses.
Descriptive analyses will characterise diagnostic and treatment patterns.
Methods
ProPCI is designed to enable future cohort multiple randomised controlled trials (cmRCTs), a 'trials within cohorts' design.
The study protocol is explicitly described as a 'trials within cohorts' (TwiCs) study.
Future cmRCT participation is a specific component of the informed consent process.
The infrastructure is intended to facilitate randomised evidence generation within the observational cohort.
This design is motivated by the rapidly evolving diagnostic and therapeutic landscape for prostate cancer.
Methods
Ethical approval was obtained from the Committee on Research Involving Human Subjects (CMO) of Radboudumc, and written informed consent covering five components is required from every participant.
Mandatory consent components include: (1) extraction and linkage of clinical, imaging, pathology and registry data, and (2) future contact for potential cmRCT participation.
Optional consent components include: (3) quality-of-life questionnaires, (4) collection of additional blood samples, and (5) use of biomaterials for genomic testing.
The modular consent structure allows patients to participate at different levels of data and sample contribution.
The trial is registered under NCT07560748.
Background
The study was motivated by the scarcity of high-quality real-world data integrating clinical, imaging, molecular, quality-of-life, and outcome information for high-risk localised prostate cancer and mHSPC.
The diagnostic and therapeutic landscape for these conditions is described as 'rapidly evolving.'
Advances cited include imaging, risk stratification, systemic therapies, and precision medicine.
The authors state that 'high-quality real-world data integrating clinical, imaging, molecular, quality-of-life information and outcome data remain scarce.'
The cohort is intended to address this evidence gap through prospective, comprehensive data collection.
What This Means
This paper describes the design and planned methods of a large Dutch research initiative called ProPCI (PROspective Prostate Cancer Infrastructure). The study will follow men diagnosed with either high-risk localised prostate cancer or prostate cancer that has already spread to other parts of the body at diagnosis (called metastatic hormone-sensitive prostate cancer). Researchers will collect detailed information from medical records, national health registries, quality-of-life questionnaires, and repeated blood samples over time. The goal is to build a rich, real-world picture of how these patients are diagnosed, treated, and how their disease progresses, while also storing biological samples that can be used to discover new markers that might predict outcomes or guide treatment choices.
One distinctive feature of ProPCI is that it is designed not just as an observational study but as a platform for future clinical trials embedded within the cohort — a 'trials within cohorts' approach. This means that once enough patients are enrolled, researchers can randomly assign subsets of participants to different treatments or interventions without needing to build entirely new trial infrastructure each time. Participants consent upfront to potentially being contacted for such future trials, making it more efficient to generate randomised evidence on questions that arise as the treatment landscape evolves.
This research suggests that a well-designed infrastructure combining real-world clinical data, patient-reported experiences, molecular biology, and a built-in trial capability could help fill important knowledge gaps about which treatments work best for which patients with advanced or high-risk prostate cancer. Because treatments for these cancers are changing rapidly — with new drugs, imaging technologies, and precision medicine approaches — this type of ongoing, flexible research platform may be particularly valuable for keeping clinical evidence up to date with practice.
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R. Wissing, T. van Elst, M. Sedelaar, R. Smeenk, P. van den Berg, J. M. van Dodewaard-de Jong, et al.. (2026). PROspective Prostate Cancer Infrastructure: study protocol for the ProPCI 'trials within cohorts' study.. BMJ Open. https://doi.org/10.1136/bmjopen-2026-121662