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Not yet recruiting NCT07560748

Prospective Prostate Cancer Infrastructure

— Observational High Risk Localized Prostate Cancer Synchronous Metastatic Hormone-Sensitive Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: High Risk Localized Prostate Cancer, Synchronous Metastatic Hormone-Sensitive Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Treatment patterns [Time frame: From diagnosis through study completion, up to 4 years]
  • PSA response [Time frame: From treatment initiation up to 12 months.]
  • PSA nadir [Time frame: From treatment initiation up to 12 months]
  • Utilization of imaging modalities for primary staging [Time frame: At baseline]
  • Time to clinical progression [Time frame: From treatment initiation through study completion, up to 4 years]
  • Time to biochemical progression [Time frame: From treatment initiation through study completion, up to 4 years]
  • Time to radiographic progression [Time frame: From treatment initiation through study completion, up to 4 years]
  • Time to castration-resistant prostate cancer (CRPC) [Time frame: From treatment initiation through study completion, up to 4 years]
  • Overall survival [Time frame: From diagnosis through study completion, up to 4 years]
  • Adverse events [Time frame: From treatment initiation through study completion, up to 4 years]
Secondary outcome measures (7)
  • Dynamic change in ctDNA fraction [Time frame: Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.]
  • Prevalence and clinical phenotypes of genomic alterations [Time frame: At diagnosis or at disease progression, up to 4 years]
  • Health-Related Quality of Life (Global Health Status) [Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.]
  • Health-Related Quality of Life (Health Utility) [Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months]
  • Pain intensity and interference [Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.]
  • Fatigue severity and interference [Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.]
  • Prostate cancer-specific symptoms [Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07560748 · 2025-18407 · NL-OMON58526

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗