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Clinical Trials in France / NCT07766122
Starting soon Phase 4

Analysis of the Performance of PSMA Emission Tomography in Patients With Prostate Cancer Treated With HIFU

NCT07766122 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Toulouse
Phase
Phase 4
Started
2026-10
Last updated
2026-08-14

Condition(s) studied

Prostate Cancer - RecurrentProstate Cancer (Diagnosis)

Investigational drug(s) / intervention(s)

Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy)

Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy): Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer p one year after treatment, multiparametric prostate MRI in accordance with current recommendations, follow-up prostate biopsy as part of routine care.

Study summary

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.

Eligibility

Sex
MALE
Min age
70 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • diagnostic performance of PSMA-PET — 12 months after treatment
    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).

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Toulouse Toulouse France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07766122 on ClinicalTrials.gov ↗ ← All trials in France