¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer

Sponsor
The University of Hong Kong
Study ID
NCT07788625
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Focal Therapy for Prostate Cancer — PROCEDURE
    Focal ablation performed under general or spinal anaesthesia with the patient in the lithotomy position. The ¹⁸F-PSMA-1007 PET-CT DICOM dataset is imported into the Koelis Trinity® platform and fused with real-time transrectal ultrasound using organ-based tracking (OBT). The urologist selects one of the following modalities based on tumour location and anatomical constraints: (1) targeted microwave ablation (TMA) using the TATO3® needle; (2) high-intensity focused ultrasound (HIFU) using the Sonablate® system; or (3) irreversible electroporation (IRE) using the NanoKnife® or PoriNova® systems. Treatment is delivered transperineally with a 5-10 mm margin around the PET-avid MRI-invisible lesion and any concurrent MRI-visible lesions, maintaining a ≥5 mm safety distance from the sphincter, rectum, and neurovascular bundles. Procedural parameters (modality, applicator numbers, treatment times, estimated ablation volumes) are recorded.

Study Details

Multiparametric magnetic resonance imaging (mpMRI) is the standard imaging modality for prostate cancer diagnosis and focal therapy planning. However, 10-20% of clinically significant prostate cancers (csPCa) are not visible on mpMRI (PI-RADS 1-2). These MRI-invisible lesions, typically identified only on systematic biopsy, are currently not targetable by MRI-guided focal therapy, leaving patients with the choice between whole-gland radical treatment or active surveillance. This prospective, multi-centre, single-arm phase II trial investigates whether pelvis-only ¹⁸F-PSMA-1007 positron emission tomography-computed tomography (PET-CT) can identify MRI-invisible csPCa and serve as the therapeutic navigation tool for focal ablation. Men aged ≥50 years with localized, intermediate-risk prostate cancer (ISUP Grade Group 2-3) and at least one MRI-invisible csPCa focus undergo a PET-CT. If a PET-avid lesion corresponds anatomically to the MRI-invisible biopsy-positive site, the patient receives focal therapy using an energy modality (targeted microwave ablation, high-intensity focused ultrasound, or irreversible electroporation) selected based on tumour anatomy, guided by organ-based tracking. The primary endpoint is the absence of csPCa (Grade Group ≥2) on 6-month targeted biopsy of all treated zones. Secondary endpoints include out-of-field recurrence, functional outcomes, and safety. The study requires 45 treated patients (total enrolment \~60) across two Hong Kong centres and will be completed within 3 years.

Key Dates

First listed
Aug 26, 2026
Start date
Aug 20, 2026
Status verified
Aug 2026
Primary completion
Aug 23, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PET-Directed Focal Therapy
    Patients with MRI-invisible csPCa who demonstrate a corresponding PET-avid lesion on ¹⁸F-PSMA-1007 PET-CT proceed to focal therapy. The ablative modality (targeted microwave ablation, high-intensity focused ultrasound, or irreversible electroporation) is selected by the treating urologist based on tumour location, anatomical constraints, and the known performance characteristics of each technology. All treatments are performed transperineally under organ-based tracking (OBT) navigation using the Koelis Trinity® platform, which fuses the PET-CT dataset with real-time transrectal ultrasound. Treatment covers the PET-positive MRI-invisible lesion and any concurrent MRI-visible lesions with a 5-10 mm intraprostatic margin, while preserving a ≥5 mm safety distance from the sphincter, rectum, and neurovascular bundles when clinically desired.

Primary Outcome Measure

Absence of clinically significant prostate cancer in treated zones at 6 months [ Time Frame: At 6 months post-treatment ]

Central Contacts

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