Clinical trial · Observational
Radio-guided Surgery With DROP-IN Beta Probe for 68Ga-PSMA, in High-risk Prostate Cancer Patients Eligible for Robotic-assisted Radical Prostatectomy.
PSMA Radio-Guided Lymph Node Dissection With Beta-Probe, in High-risk Prostate Cancer Patients.
NCT05596851CI-TRIAL-00061772unknownClinicalTrials.gov clinicaltrialsProvenance
- 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 goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Positron Emission Tomography | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| PSMA | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity, specificity and positive predictive value in a per-region analysis
- timeFrame
- March 2022 - March 2023
Secondary outcomes (3)
- measure
- Comparison of β-probe intra-operatory measurements with ex-vivo ones.
- timeFrame
- March 2022 - March 2023
- measure
- Comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters
- timeFrame
- March 2022 - March 2023
- description
- SUVmax and PSMA-TV will be evaluated as semi-quantitative parameters
- measure
- Comparison of β-probe measurements and PSMA expression assessed by immunohistochemical analysis (IHC).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate cancer * High-risk prostate cancer (T\>T2c and/or PSA\>20 and/or ISUP\>3) * Patients suitable for radical prostatectomy + pelvic lymph node dissection * 68Ga-PSMA-11 PET/CT performed within 4 weeks prior to surgery * PSMA positive pelvic lymph nodes detected at 68Ga-PSMA-11 PET/CT * Age \>18 years old * Willing to sign informed consent Exclusion Criteria: * Patient unfit for surgery * M1 stage (any M) detected at 68Ga-PSMA-11 PET/CT or other imaging modalities performed during diagnostic wok-up evaluation * Unable to tolerate PET scan
References
Publications (0)
Data not yet available
No reference posted for this study.