Prostate Cancer - RecurrentPhase 4ECETEPNCT07766122
Analysis of the Performance of PSMA Emission Tomography in Patients With Prostate Cancer Treated With HIFU
A Phase 4 study testing Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy) in people with Prostate Cancer - Recurrent and Prostate Cancer (Diagnosis), run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, men only
- Conditions the study is for
- Prostate Cancer - Recurrent, Prostate Cancer (Diagnosis)
- What is being tested?
- Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2027to Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jeremy MERCIER, MD-PH contact
France1 site
University Hospital of Toulouse
Toulouse
Anne-Sophie BAJEOT, MD-PH, 05 61 32 35 49 ext. +33, bajeot.as@chu-toulouse.fr
Jeremy MERCIER, MD-PH, Mercier.j@chu-toulouse.fr
About this study
Official title: 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.
Read the 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.
- Being tested
- Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy)
- Keywords
- prostate cancer, focal treatment, focal therapy, high-intensity focused ultrasound (HIFU), PET PSMA, prostate MRI, recurrence, post-treatment follow-up, functional nuclear imaging
- Medical subject headings
- Prostatic Neoplasms, Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 p one year after treatment, multiparametric prostate MRI in accordance with current recommendations, follow-up prostate biopsy as part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| Nuclear imaging (PSMA PET) | Experimental | Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy) Receives: Drug: Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startFeb 2027 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer - RecurrentStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766122
- Sponsor's protocol ID
- RC31/25/0648
- Other IDs
- 2026-525181-22-00
- Acronym
- ECETEP
- Status last verified
- Nov 2026
- First submitted
- 10 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating PSMA Positron Emission Tomography for Monitoring Clinically Significant Prostate Cancer After Focal HIFU Treatment
- ClinicalTrials.gov ID
- NCT07766122
- Acronym / sponsor ID
- ECETEP / RC31/25/0648
- Keywords
- prostate cancer, focal treatment, focal therapy, high-intensity focused ultrasound (HIFU), PET PSMA, prostate MRI, recurrence, post-treatment follow-up
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nuclear imaging (PSMA PET) | Experimental | 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 one year after treatment (focal therapy) |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Nuclear imaging (PSMA PET) |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy MERCIER, MD-PH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nuclear imaging (PSMA PET) with intravenous injection of a radiotracer one year after treatment (focal therapy) in people with Prostate Cancer - Recurrent and Prostate Cancer (Diagnosis), run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie BAJEOT, MD-PH (05 61 32 35 49 ext. +33, bajeot.as@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic performance of PSMA-PET (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.