NCT07766122

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
24mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Prostate Cancer - RecurrentProstate Cancer (Diagnosis)

Keywords

prostate cancerfocal treatmentfocal therapyhigh-intensity focused ultrasound (HIFU)PET PSMAprostate MRIrecurrencepost-treatment follow-upfunctional nuclear imaging

Outcome Measures

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).

    12 months after treatment

Study Arms (1)

Nuclear imaging (PSMA PET)

EXPERIMENTAL

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)

Interventions

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.

Nuclear imaging (PSMA PET)

Eligibility Criteria

Age70 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailspresence of prostate
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Prostatic NeoplasmsDiseaseRecurrence

Interventions

Aftercare

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Continuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Anne-Sophie BAJEOT, MD-PH

CONTACT

05 61 32 35 49bajeot.as@chu-toulouse.fr

Jeremy MERCIER, MD-PH

CONTACT

Mercier.j@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

August 14, 2026

Record last verified: 2026-08

Locations

FR(1)