Prospective Prostate Cancer Infrastructure

NCT07560748 | Not Yet Recruiting

• 2 other identifiers: 2025-18407NL-OMON58526
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

High Risk Localized Prostate Cancer; Synchronous Metastatic Hormone-Sensitive Prostate Cancer

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (7)

• Dynamic change in ctDNA fraction

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

• Prevalence and clinical phenotypes of genomic alterations

  At diagnosis or at disease progression, up to 4 years

• Health-Related Quality of Life (Global Health Status)

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

• Health-Related Quality of Life (Health Utility)

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

• Pain intensity and interference

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Written informed consent
• Able to understand one of the following languages sufficiently: Dutch, English, Arabic or Turkish.

You may not qualify if:

• Not currently living in the Netherlands.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04