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

RecruitingNAAges 50 Years - anyMaleThe University of Hong Kong
NCT07788625 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 PE

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Men aged ≥50 years 2. Life expectancy \>10 years 3. Histologically confirmed localized prostate cancer, ISUP Grade Group 2 or 3 4. 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 5. 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 6. Organ-confined disease on mpMRI and no evidence of seminal vesicle invasion or lymph node/distant metastasis 7. Serum PSA \<20 ng/mL 8. Able to provide informed consent Exclusion Criteria: 1. Previous treatment for prostate cancer (radiotherapy, surgery, focal therapy, androgen deprivation) 2. Prior pelvic radiotherapy for any cause 3. Contraindication to MRI or gadolinium contrast 4. Contraindication to PSMA PET-CT (e.g. severe claustrophobia, inability to lie flat) 5. Contraindication to general or spinal anaesthesia 6. 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) 7. Active urinary tract infection or acute prostatitis 8. 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 9. Bladder pathology (bladder stone, bladder cancer) or known urethral stricture
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What it tests

  • Focal Therapy for Prostate Cancer
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Where

1 site
Queen Mary Hospital
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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