MedTrace Logo

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

NCT07788625 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Focal Therapy for Prostate Cancer

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.

Sponsors & Collaborators

  • Queen Mary Hospital, Hong Kong

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2029-08-23
Completion
2029-11-30

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788625 on ClinicalTrials.gov