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NCT07766122
Analysis of the Performance of PSMA Emission Tomography in Patients With Prostate Cancer Treated With HIFU
Conditions: Prostate Cancer - Recurrent, Prostate Cancer (Diagnosis)
Sex: Male
Ages: 70 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 30
Sponsor: University Hospital, Toulouse
Location: University Hospital of Toulouse Toulouse
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 Criteria
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
Source: ClinicalTrials.gov (NCT07766122). StuddyBuddy aggregates publicly available trial information.