Clinical trial · Observational
Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer
The Clinical Impact and Prognostic Value of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer: Real-world Evidence From a Monocentric, Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The introduction of PSMA diagnostics and therapy has fundamentally changed the treatment management of prostate cancer and has significantly replaced other clinical and radiological diagnostic methods. As a result, 18F-PSMA-1007 (Radelumin®) was approved in Germany and several EU countries, most recently in Germany in 01/2024, for use in primary staging of high-risk prostate cancer and re-staging in the context of biochemical recurrence (BCR). This could be seen as a milestone in the management of prostate cancer and will significantly promote the widespread use of PSMA-PET diagnostics in the coming years. The investigators now intend to prospectively generate evidence-based data in everyday clinical practice with this so-called Real-World-Evidence (RWE) study. The planned study will enable us to analyze the diagnostic accuracy of Radelumin® in more detail under everyday conditions, whereby dedicated examinations of certain subgroups and the prospective generation of a complete, high-quality database for the future use of artificial intelligence (AI) will be made possible.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic Accuracy and Prognostic Value of [18F]PSMA-1007 PET/CT in Primary Staging of Prostate Cancer
- timeFrame
- Interim analyses will be performed annually, with a final analysis at 5 years.
- description
- 1. The primary outcome will assess the diagnostic accuracy of \[18F\]PSMA-1007 PET/CT by comparing its sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) against histopathological confirmation or composite clinical follow-up as the reference standard. 2. The prognostic value will be evaluated by analyzing the association between baseline PSMA PET/CT-derived parameters (e.g., SUVmax, tumor burden, lesion distribution) and oncological outcomes, including biochemical recurrence-free survival and progression-free survival. 3. Quantitative PET parameters will be extracted using a standardized semi-automated segmentation method, and survival analysis will be conducted using Kaplan-Meier estimates and Cox proportional hazards models.
Secondary outcomes (1)
- measure
- Correlation of PET Parameters with Clinical and Pathological Features Description
- timeFrame
- Evaluated at 1-year, 2-year, and 5-year follow-up.
- description
- 1. The correlation between PET-derived quantitative parameters (SUVmax, metabolic tumor volume \[MTV\], total lesion PSMA expression \[TLPE\]) and clinical/pathological factors (Gleason Score, PSA level, tumor stage, lymph node involvement) will be assessed. 2. The proportion of patients whose management plan (e.g., radical prostatectomy, radiotherapy, systemic therapy) changed due to PSMA PET/CT findings compared to conventional imaging. Measured by documenting pre- and post-imaging treatment plans and analyzing changes in therapeutic strategies. 3. The relationship between baseline PSMA PET/CT findings and biochemical recurrence free survival (BRFS) will be analyzed using Kaplan-Meier survival analysis and Cox proportional hazards modeling.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \> 18 years * Planned \[18F\]PSMA-1007 PET/CT examination in patients with a first diagnosis of prostate cancer * Informed consent Exclusion Criteria: \- Examinations with limited assessability due to technical errors, such as imaging artifacts.
References
Publications (0)
Data not yet available