Not Yet RecruitingNot Applicable

Prospective Prostate Cancer Infrastructure

700 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment patterns

Timeframe: From diagnosis through study completion, up to 4 years

PSA response

Timeframe: From treatment initiation up to 12 months.

PSA nadir

Timeframe: From treatment initiation up to 12 months

Utilization of imaging modalities for primary staging

Timeframe: At baseline

Time to clinical progression

Timeframe: From treatment initiation through study completion, up to 4 years

Time to biochemical progression

Timeframe: From treatment initiation through study completion, up to 4 years

Time to radiographic progression

Timeframe: From treatment initiation through study completion, up to 4 years

Trial details

NCT IDNCT07560748

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-05

View on ClinicalTrials.gov More High Risk Localized Prostate Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Treatment patterns

Timeframe: From diagnosis through study completion, up to 4 years

PSA response

Timeframe: From treatment initiation up to 12 months.

PSA nadir

Timeframe: From treatment initiation up to 12 months

Utilization of imaging modalities for primary staging

Timeframe: At baseline

Time to clinical progression

Timeframe: From treatment initiation through study completion, up to 4 years

Time to biochemical progression

Timeframe: From treatment initiation through study completion, up to 4 years

Time to radiographic progression

Timeframe: From treatment initiation through study completion, up to 4 years