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

NCT07788625 | Recruiting

• 1 other identifier: UW 26-323
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

Prostate Cancer; PSMA PET-CT; ¹⁸F-PSMA-1007; MRI-Invisible; Focal Therapy; Targeted Microwave Ablation; High-Intensity Focused Ultrasound; Irreversible Electroporation; Organ-Based Tracking

Outcome Measures

Primary Outcomes (1)

• Absence of clinically significant prostate cancer in treated zones at 6 months

  Proportion of patients with no csPCa (ISUP Grade Group ≥2) on targeted biopsy of all treated areas (PET-positive MRI-invisible lesion + any concurrent MRI-visible lesion) at 6 months after focal therapy (per-patient analysis).

  At 6 months post-treatment

Secondary Outcomes (9)

• Per-lesion absence of csPCa at 6 months

  At 6 months post-treatment

• Any prostate cancer in treated zones at 6 months

  At 6 months post-treatment

• Out-of-field recurrence at 6 months

  At 6 months post-treatment

• Change in serum PSA from baseline to 6 months

  Baseline to 6 months post-treatment

• Proportion of PET-positive cases among MRI-invisible csPCa

  At baseline (PET-CT)

Study Arms (1)

PET-Directed Focal Therapy

EXPERIMENTAL

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.

Procedure: Focal Therapy for Prostate Cancer

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.

Also known as: Targeted Microwave Ablation, High-Intensity Focused Ultrasound, Irreversible Electroporation, TMA, HIFU, IRE, PET/ultrasound fusion-guided ablation

PET-Directed Focal Therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged ≥50 years
• Life expectancy \>10 years
• Histologically confirmed localized prostate cancer, ISUP Grade Group 2 or 3
• At least one clinically significant cancer focus (≥1 systematic biopsy core with Grade Group 2-3) that is MRI-invisible, defined as:
• \- The corresponding sextant/region on mpMRI (performed within 6 months) shows PI-RADS v2.1 score 1 or 2, or no identifiable lesion that could account for the positive biopsy
• Total of 1-2 discrete cancer foci (MRI-visible + PET-detected MRI-invisible) on study entry, with each MRI-visible focus having maximum diameter ≤15 mm on mpMRI
• Organ-confined disease on mpMRI and no evidence of seminal vesicle invasion or lymph node/distant metastasis
• Serum PSA \<20 ng/mL
• Able to provide informed consent

You may not qualify if:

• Previous treatment for prostate cancer (radiotherapy, surgery, focal therapy, androgen deprivation)
• Prior pelvic radiotherapy for any cause
• Contraindication to MRI or gadolinium contrast
• Contraindication to PSMA PET-CT (e.g. severe claustrophobia, inability to lie flat)
• Contraindication to general or spinal anaesthesia
• Uncorrectable coagulopathy (INR \>1.5, platelet \<50×10⁹/L) or anticoagulant/antiplatelet therapy that cannot be stopped (low-dose aspirin 80-100 mg is permitted)
• Active urinary tract infection or acute prostatitis
• MRI-invisible focus located in a region where focal therapy would likely cause sphincter or rectal injury, as determined by biopsy mapping and anatomical constraints
• Bladder pathology (bladder stone, bladder cancer) or known urethral stricture

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, 香港島, Hong Kong

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Central Study Contacts

Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM

CONTACT

+852 2255 4852; jslleung@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 26, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): August 23, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

HK (1)