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

August 10, 2026 updated by: University Hospital, Toulouse

Pilot Study Evaluating PSMA Positron Emission Tomography for Monitoring Clinically Significant Prostate Cancer After Focal HIFU Treatment

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The management of localised prostate cancer (PaC) in men with favourable risk factors is contentious, often involving whole prostate treatment due to its multifocal nature in 40% of cases. Active surveillance (AS) is increasingly used to mitigate overtreatment risks in well-selected patients, supported by long-term data from large cohorts. Focal therapy is emerging as an alternative, aiming for effective cancer control while minimizing morbidity, with radical treatment available for relapse. High-intensity focused ultrasound (HIFU) shows promise for focal therapy, supported by the HIFI-1 study and the HAS report (November 2023), indicating its non-inferiority to radical prostatectomy in controlling intermediate-risk disease with less morbidity.PSMA PET imaging aids in diagnosing and assessing prostate cancer risk at diagnosis and after treatment, guiding management decisions. However, ultrasound artefacts can hinder MRI interpretation post-HIFU treatment. PSMA PET, particularly using PRIMARY score and PROMISE V2 criteria, helps in assessing disease extent, akin to miTNM classification based on cancer location and spread on molecular imaging. Overall, integrating these technologies and criteria improves the precision of prostate cancer diagnosis, risk estimation, and treatment planning The aim of this study is to evaluate the effectiveness of positron emission tomography (PSMA PET) compared with MRI in detecting clinically significant recurrence of prostate cancer (PaC) after treatment with HIFU. The aim is to measure the sensitivity and specificity of these two imaging modalities one year after treatment, with a view to improving the post-treatment follow-up strategy for PaC Patients with low intermediate risk prostate cancer with specific criteria (HAS 2023) will be included in the study. Pre-operative nuclear imaging will be performed in addition to routine diagnostic tests. Routine follow-up at 6 months will include a digital rectal examination (DRE) and PSA and Phi index measurements. At 1 year, in addition to routine follow-up (DRE, PSA, Phi index, MRI and prostate biopsy), patients will undergo a PSMA PET scan.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nuclear imaging (PSMA PET)
Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy)
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic performance of PSMA-PET
Time Frame: 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).
12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 14, 2026

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/25/0648
  • 2026-525181-22-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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