OncoMatch/Clinical Trials/NCT07788625
¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer
Is NCT07788625 recruiting? Yes, currently enrolling (Sep 2026). This NA trial studies non-drug interventions for prostate cancer.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage LOCALIZED
Grade: ISUP Grade Group 2, ISUP Grade Group 3 (ISUP)
Histologically confirmed localized prostate cancer, ISUP Grade Group 2 or 3
Demographics
Prior therapy
Cannot have received: prostate cancer therapy (radiotherapy, surgery, focal therapy, androgen deprivation)
Previous treatment for prostate cancer (radiotherapy, surgery, focal therapy, androgen deprivation)
Cannot have received: pelvic radiotherapy
Prior pelvic radiotherapy for any cause
Lab requirements
Blood counts
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)
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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07788625 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage LOCALIZED is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages