NCT07788625Recruiting
¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer
Seeing the Unseen: ¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer (The FOCUS-PSMA Study)
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- 20 Aug 2026
- Primary completion date
- 23 Aug 2029
- Lead sponsor
- The University of Hong Kong
- Diseases
- Prostate cancer
- NCT number
- NCT07788625
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 20 Aug 2026 to the primary completion date, 23 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment for prostate cancer (radiotherapy, surgery, focal therapy, androgen deprivation)
- Prior pelvic radiotherapy for any cause
- 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
Other illness
- Active urinary tract infection or acute prostatitis
- Bladder pathology (bladder stone, bladder cancer) or known urethral stricture
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.