Prospective Prostate Cancer Infrastructure for High-Risk and Metastatic Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational infrastructure aims to gather detailed real-world data and biological samples from men with high-risk localized prostate cancer or synchronous metastatic hormone-sensitive prostate cancer. The study will document how treatments are used in routine practice and their impact on patients’ quality of life, while enabling future cohort-multiple randomized trials. Data and biomaterials collected can support biomarker discovery and enhanced patient matching for future research. No interventions are specified as part of this observational setup, which is conducted at Radboud University Medical Center in the Netherlands. Eligible participants include adults with specific diagnostic criteria and language compatibility who provide informed consent.

Why it matters

Who can join: the full rules

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.

Where it's running

• Radboud University Medical Center
  Nijmegen, Netherlands Recruiting

Study contacts

• Study coordinator: Niven Mehra, PhD
• Email: niven.mehra@radboudumc.nl
• Phone: +3124 361 88 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.