Clinical trial · Observational
Prospective Prostate Cancer Infrastructure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Localized Prostate Cancer | — | UNRESOLVED | — |
| Synchronous Metastatic Hormone-Sensitive Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (12)
- measure
- Treatment patterns
- timeFrame
- From diagnosis through study completion, up to 4 years
- description
- 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.
- measure
- PSA response
- timeFrame
- From treatment initiation up to 12 months.
- description
- Proportion of patients achieving \>50% and \>90% PSA decline from baseline within the first year after treatment initiation.
- measure
- PSA nadir
- timeFrame
- From treatment initiation up to 12 months
- description
- Lowest PSA value achieved within 1 year after treatment initiation and time from treatment initiation to PSA nadir.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Ruben O Wissing, Tessa van Elst, Michiel Sedelaar et al. · BMJ Open · Sep 11, 2026 · PMID 42731831 pubmed