Clinical trial · Observational
Predictors of Nodal and Distant Metastatic Disease Detected by PSMA PET in Treatment-Naïve High-Risk Prostate Cancer: A Czech Multicentre Cohort 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)
Prostate cancer is the second most common malignancy worldwide and the fifth leading cause of male cancer-related mortality. Approximately 15% of localized cases are classified as high-risk for biochemical recurrence. These patients frequently harbour occult metastases undetected by conventional imaging (CT and bone scintigraphy). Consequently, PSMA PET has revolutionized primary staging and is strongly recommended by EAU guidelines. In the Czech Republic, a transition toward a "PSMA-first" pathway is evident, where molecular imaging increasingly replaces conventional modalities. This "stage-migration" identifies a new cohort of miN1/M1 patients previously classified as having localized disease. However, PSMA PET is a resource-demanding modality and not yet universally available. To optimize its utility, identifying which combinations of routinely available parameters predict metastatic disease and characterizes this new cohort is essential. Furthermore, real-world evidence regarding early oncological outcomes within this PSMA-only framework is limited. This multicentre cohort study aims to define a multiparametric predictive model for PSMA-detected metastases and evaluate the real-world therapeutic trajectories and follow-up outcomes of this newly defined high-risk population. Integrating clinical, biological, and molecular data, seeks to refine patient selection and provide a longitudinal perspective on the "PSMA-first" diagnostic era.
Conditions
Conditions (4)
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 Prostate Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| PSMA PET | — | UNRESOLVED | — |
| Staging | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- High-risk localized or locally advanced PCa before treatment
- interventionNames
- Diagnostic Test: PSMA PET
Primary outcomes (1)
- measure
- Area Under the Receiver Operating Characteristic (AUC ROC) [scale 0 to 1] of multiparametric model for miN1 and/or miM1 on PSMA (prostate specific membrane antigen) PET (positron emission tomography) according to PROMISE (prostate cancer) V2 criteria.
- timeFrame
- Data collected at the time of result of PSMA PET/CT imaging, approximately 1 month after.
- description
- This predictive model aggregates heterogeneous predictors into a single numerical probability score to determine the presence of metastasis by multivariate logistical regression. The model will include: serum PSA (prostate specific antigen) \[μg/ml\] and/or PSA density \[μg/ml/cc\], clinical T stage \[T1a/b/c, T2a/b/c, T3a/b, T4\], prostate biopsy ISUP GG - International Society of Urology Pathology Grade Group \[1/2/3/4/5\], and the presence of a cribriform growth pattern, multiparametric MRI (magnetic resonance imaging) PI-RADS (Prostate Imaging Reporting and Data System) v2.1 score \[1/2/3/4/5\], as well as SUVmax (maximum standardized uptake value) \[g/ml\] and PSMA PET total tumor volume \[ml\] of the primary intraprostatic lesion. Higher scores/values indicate more aggressive disease.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria Male patients will be included if: * Male patients aged ≥ 18 years with histologically confirmed prostate adenocarcinoma, * high-risk disease defined as ISUP GG ≥ 4 and/or PSA ≥ 20 ng/ml and/or clinical stage assessed by DRE ≥ cT2c, * PSMA PET performed for primary staging within study window. Exclusion Criteria Patients with: * definitive local treatment (e.g., radical prostatectomy or radiation therapy) or systemic treatment (e.g., androgen deprivation therapy) administered prior to primary staging with PSMA PET, * low or intermediate-risk PCa as defined by failing to meet any of the inclusionary high-risk parameters, * incomplete or fragmented medical records that preclude the accurate extraction of primary staging parameters (PSA, ISUP GG, clinical T-stage) or PSMA PET results (miN/miM status), * active malignancy requiring systemic treatment at the time of PSMA PET.
References
Publications (0)
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