Clinical trial · Interventional
Analysis of the Performance of PSMA Emission Tomography in Patients With Prostate Cancer Treated With HIFU
Pilot Study Evaluating PSMA Positron Emission Tomography for Monitoring Clinically Significant Prostate Cancer After Focal HIFU Treatment
- 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)
There would appear to be a strong interest in functional nuclear imaging for assessing the response to focal PaC treatment. Investigator team hypothesise that the diagnostic performance of PSMA PET is noninferior to that of MRI in detecting clinically significant recurrent PaC after treatment with HIFU. The main objective was to evaluate the diagnostic performance of PSMA PET compared with MRI with reference to the gold standard of prostate biopsy one year after HIFU.
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 |
|---|---|---|---|
| Prostate Cancer (Diagnosis) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
| Prostate Cancer - Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nuclear imaging (PSMA PET)
- description
- Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy)
- interventionNames
- Drug: Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy)
Primary outcomes (1)
- measure
- diagnostic performance of PSMA-PET
- timeFrame
- 12 months after treatment
- description
- Measurement of the sensitivity and specificity of PSMA PET in the diagnosis of recurrence of significant prostate cancer one year after treatment with HIFU: the result will be considered positive (indicating a recurrence of prostate cancer) if the PSMA intensity score (SUV max) is 4.0 or higher; the presence of a recurrence of prostate cancer at the 1-year follow-up will be confirmed by biopsies (Gold Standard).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with prostate cancer * Age ≥ 70 years (HAS 2023) * Life expectancy \> 5 years * Clinical stage Clinical stage T1c - T2a PSA \< 20 ng/ml Biopsy :ISUP 2 unilateral on a maximum of 2 contiguous sextants with or without ipsilateral or contralateral focus ISUP1 single focus or multiple foci if only one ISUP 2 focus on targeted biopsy * Imaging Single lesion PIRADS 3 or 4 or 5 Volume of prostate gland \< 150 ml * Enrolled in a social security scheme * Signature of consent Exclusion Criteria: * Evidence of extra-prostatic extension or invasion of the seminal vesicles. * Any condition that, in the judgement of the investigators, would interfere with the subject's ability to * provide informed consent, comply with study instructions, expose the subject to increased risk, or interfere with the interpretation of study results. * Patients deprived of their liberty or under legal protection (curatorship and guardianship, safeguard of justice) * Hypersensitivity to the active substances or to any of the excipients * Conditions contraindicating magnetic resonance imaging (MRI), such as the presence of internal metallic devices. * Chronic kidney disease with an eGFR ≤ 60 mL/min * Liver failure
References
Publications (0)
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