Analysis of the Performance of PSMA Emission Tomography in Patients With Prostate Cancer Treated With HIFU
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age70+
SponsorUniversity Hospital, Toulouse
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy)
DrugNuclear 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Nuclear imaging (PSMA PET)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
diagnostic performance of PSMA-PET
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).
Time frame
12 months after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: