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High Risk Localized Prostate CancerProPCINCT07560748

Prospective Prostate Cancer Infrastructure

An observational study of High Risk Localized Prostate Cancer and Synchronous Metastatic Hormone-Sensitive Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
How many people
700 participants
Where
1 siteNetherlands
Study dates
1 Sep 2026to Sep 2030
How long will I take part?
48 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Not currently living in the Netherlands.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Niven Mehra, PhD contact

+3124 361 88 00

niven.mehra@radboudumc.nl

Netherlands1 site, 1 recruiting

  • Radboud University Medical Center

    Nijmegen

    Recruiting

Other trials in Netherlands

About this study

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. PSA response

    Proportion of patients achieving >50% and >90% PSA decline from baseline within the first year after treatment initiation.

    Measured: From treatment initiation up to 12 months.

  3. PSA nadir

    Lowest PSA value achieved within 1 year after treatment initiation and time from treatment initiation to PSA nadir.

    Measured: From treatment initiation up to 12 months

  4. 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.

    Measured: At baseline

  5. 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.

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

  6. 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.

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

  7. Time to radiographic progression

    Time from treatment initiation to radiographic progression based on imaging (conventional imaging, PSMA PET/CT), or RECIST 1.1 criteria.

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

  8. Time to castration-resistant prostate cancer (CRPC)

    Time from treatment initiation to castration-resistant prostate cancer (CRPC) per PCWG3 criteria.

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

  9. Overall survival

    Time from diagnosis to death from any cause.

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

  10. 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.

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

  11. Number of hospital admissions

    Total number of planned and unplanned hospital admissions.

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

  12. Number of outpatient visits

    Total number of outpatient visits

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

Secondary outcomes (7)

  1. Dynamic change in ctDNA fraction

    Change in ctDNA fraction at 4-6 weeks and 9 months after start of initial treatment.

    Measured: Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.

  2. 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.

    Measured: At diagnosis or at disease progression, up to 4 years

  3. 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.

    Measured: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

  4. 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.

    Measured: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months

  5. Pain intensity and interference

    Change in average pain score and pain interference score measured using the Brief Pain Inventory - Short Form (BPI-SF).

    Measured: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

  6. Fatigue severity and interference

    Change in average fatigue score and fatigue interference score measured using the Brief Fatigue Inventory (BFI).

    Measured: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

  7. 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.

    Measured: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start1 Sep 2026
  3. Primary completionSep 2030 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
700 participants (estimated)
Target duration
48 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07560748
Sponsor's protocol ID
2025-18407
Other IDs
NL-OMON58526, 2025
Acronym
ProPCI
Status last verified
Sep 2026
First submitted
16 Apr 2026
Last updated
10 Sep 2026
Results posted
No

Publications

  • Wissing RO, van Elst T, Sedelaar M, Smeenk RJ, van den Berg P, van Dodewaard-de Jong JM, Lont AP, Hendriks MP, Luijendijk-de Bruin D, van de Luijtgaarden ACM, Roelofs LAJ, Vis AN, Hoekstra RJ, Bloemendal HJ, van Basten JA, Mehra N. PROspective Prostate Cancer Infrastructure: study protocol for the ProPCI 'trials within cohorts' study. BMJ Open. 2026 Sep 11;16(9):e121662. doi: 10.1136/bmjopen-2026-121662.

    PubMed 42731831

Questions about this trial

What is this clinical trial studying?

An observational study of High Risk Localized Prostate Cancer and Synchronous Metastatic Hormone-Sensitive Prostate Cancer, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Niven Mehra, PhD (+3124 361 88 00, niven.mehra@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment patterns (time frame: From diagnosis through study completion, up to 4 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07560748, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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