¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyźni w wieku 50 lat lub starsi
- •Spodziewana długość życia powyżej 10 lat
- •Potwierdzony histologicznie rak prostaty bez przerzutów, stopnia agresywności 2 lub 3
- •Co najmniej jedna zmiana rakowata niewidoczna w MRI, ale stwierdzona w biopsji
- •Maksymalnie 1-2 ogniska raka w prostatie
- •Brak zajęcia pęcherzyka nasiennego lub węzłów chłonnych
- •Wartość PSA poniżej 20 ng/mL
- •Zdolność do wyrażenia świadomej zgody
✗ Disqualifies
- •Poprzednie leczenie raka prostaty (radioterapia, operacja lub inna terapia ogniskowa)
- •Wcześniejsza radioterapia miednicy
- •Niemożność wykonania MRI lub zastosowania środka kontrastowego
- •Niemożność wykonania PET-CT (np. klaustrofobia, niemożność leżenia)
- •Niemożność podania znieczulenia ogólnego lub punktowego
- •Zaburzenia krzepnięcia krwi, które nie można skorygować
- •Aktywne zapalenie dróg moczowych lub gruczołu krokowego
- •Zmiana niewidoczna w MRI umiejscowiona w miejscu, gdzie leczenie mogłoby uszkodzić ważne struktury
Simplified criteria — AI translation
Trial details
- Minimum age
- 50 Years
- Last updated (source)
- August 26, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Queen Mary Hospital
Hong Kong, Hong Kong
Trial contact
Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/27/2026.
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