Prostate CancerFOCUS-PSMANCT07788625
¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer
A study testing Focal Therapy for Prostate Cancer in people with Prostate Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal Therapy for Prostate Cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Aug 2026to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, 香港島
Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM, +852 2255 4852, jslleung@hku.hk
Yusra Saleem, BSc, +852 2255 4852, yusra@hku.hk
About this study
Official title: Seeing the Unseen: ¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer (The FOCUS-PSMA Study)
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.
Read the detailed description
This is a prospective, multi-centre, single-arm Phase II trial conducted at Queen Mary Hospital and Princess Margaret Hospital, Hong Kong. The study adheres to the Declaration of Helsinki and ICH-GCP guidelines, with ethics approval obtained prior to initiation. Eligible patients are men aged ≥50 years, life expectancy >10 years, with histologically confirmed localized prostate cancer (ISUP Grade Group 2 or 3), at least one csPCa focus identified on systematic biopsy that is MRI-invisible (PI-RADS v2.1 score 1-2 in the corresponding region), total of 1-2 discrete cancer foci, PSA <20 ng/mL, and organ-confined disease. Exclusion criteria include prior prostate cancer treatment, pelvic radiotherapy, contraindications to MRI or PSMA PET-CT, and uncorrectable coagulopathy.
Enrolled patients undergo a dedicated pelvis-only ¹⁸F-PSMA-1007 PET-CT within 4 weeks of enrolment. No fasting is required; activity is weight-based. After a 90-minute uptake period, low-dose non-contrast CT and PET imaging of the pelvis are acquired. Iterative reconstruction optimised for small lesion detection is applied. A PRIMARY-adapted five-point PET-score system (1 to 5) is used; focal uptake scoring 3, 4, or 5 defines a PET-positive lesion. Only patients with a PET-positive lesion anatomically correlated with the MRI-invisible biopsy-positive location proceed to focal therapy.
Focal therapy is performed under general or spinal anaesthesia. 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 the ablative modality based on tumour location and constraints from the following: targeted microwave ablation (TMA) using the TATO3® needle; high-intensity focused ultrasound (HIFU) using the Sonablate® system; or irreversible electroporation (IRE) using the NanoKnife® or PoriNova® systems. Treatment is transperineal, with a 5-10 mm intraprostatic margin around the PET-avid and any concurrent MRI-visible lesions, while maintaining a ≥5 mm safety distance from sphincter, rectum, and neurovascular bundles.
Follow-up includes PSA, adverse events, and validated questionnaires (IPSS, IIEF-5, EPIC-26) at month 3 and month 6. At month 6, a repeat mpMRI and transperineal MRI/ultrasound fusion biopsy (3-4 cores per treated area plus a 12-core systematic template) are performed. Pathology is read by dedicated uropathologists with ISUP Grade Group reporting per core and per lesion. Primary outcome: per-patient absence of csPCa (≥ Grade Group 2) on targeted biopsy of all treated zones at 6 months. Secondary outcomes: any cancer in treated zones, out-of-field recurrence, PSA kinetics, functional score changes, adverse events (Clavien-Dindo), quality of life, PET positivity proportion among enrolled patients, and technical success of PET/US fusion.
Sample size uses A'Hern's single-stage phase II design. With an assumed true in-field success rate (p₁) of 0.88 and an unacceptable threshold (p₀) of 0.73, one-sided α=0.05, power=0.80, the critical value is 34 successes out of 40 treated patients. Accounting for a 10% loss to follow-up/biopsy, 45 treated patients are required. Estimating that 75% of enrolled MRI-invisible csPCa patients will have a PET-avid lesion, a total of 60 patients will be enrolled. Recruitment over 24 months is feasible across the two centres, each performing ~200 MRI-guided biopsies annually, with ~15% revealing MRI-invisible csPCa. The primary analysis will be performed on the protocol population; the proportion achieving the primary endpoint will be reported with an exact 95% confidence interval. Secondary endpoints will be analysed using paired t-tests or Wilcoxon signed-rank tests for continuous variables, and McNemar or chi-square tests for categorical variables, with p<0.05 considered significant. SPSS will be used.
Data will be handled in accordance with Hospital Authority policies. Personal data will be coded, stored in locked cabinets and password-protected servers with restricted access, and retained for 10 years post-completion before destruction. Patients who are PET-negative will be managed per institutional standard, with their data collected for secondary analyses. The study is funded by The University of Hong Kong, with consumables for IRE and TMA provided free of charge by Zhejiang CuraWay Medical Technology Co., Ltd. and Chindex Hong Kong Limited, respectively.
- Conditions
- Prostate Cancer
- Being tested
- Focal Therapy for 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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal Therapy for Prostate CancerProcedure or surgery
Also called Targeted Microwave Ablation, High-Intensity Focused Ultrasound, Irreversible Electroporation, TMA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Focal Therapy for Prostate Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 6 months post-treatment
Secondary outcomes (9)
Per-lesion absence of csPCa at 6 months
Per-lesion analysis of absence of csPCa (ISUP Grade Group ≥2) at 6 months in: (a) PET-guided treated zones, and (b) MRI-guided treated zones.
Measured: At 6 months post-treatment
Any prostate cancer in treated zones at 6 months
Presence of any prostate cancer (ISUP Grade Group ≥1) in treated zones at 6 months
Measured: At 6 months post-treatment
Out-of-field recurrence at 6 months
Presence of any cancer (ISUP Grade Group ≥1) on systematic biopsy outside treatment zones at 6 months.
Measured: At 6 months post-treatment
Change in serum PSA from baseline to 6 months
Absolute and percentage change in serum PSA from baseline to 6 months.
Measured: Baseline to 6 months post-treatment
Proportion of PET-positive cases among MRI-invisible csPCa
Proportion of enrolled MRI-invisible csPCa patients who demonstrate a PET-positive corresponding lesion (feasibility of PET guidance).
Measured: At baseline (PET-CT)
Change in International Prostate Symptom Score (IPSS)
IPSS assesses urinary symptoms with a range of 0 to 35. Higher scores indicate worse urinary symptoms.
Measured: Baseline to 3 months and 6 months post-treatment
Adverse events
Adverse events graded by the Clavien-Dindo classification. Serious adverse events (SAE) defined as any event resulting in death, unplanned ICU admission, or re-operation.
Measured: Intraoperative and up to 6 months post-treatment
Change in International Index of Erectile Function-5 (IIEF-5)
IIEF-5 assesses erectile function with a range of 1 to 25. Lower scores indicate worse erectile function
Measured: Baseline to 3 months and 6 months post-treatment
Change in EPIC-26 urinary continence domain score
The EPIC-26 urinary continence domain assesses urinary function with a range of 0 to 100. Higher scores indicate better urinary continence function.
Measured: Baseline to 3 months and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion23 Aug 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, LEUNG SHUNG LAI JOHN, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788625
- Sponsor's protocol ID
- UW 26-323
- Acronym
- FOCUS-PSMA
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tosoian JJ, Mamawala M, Epstein JI, Landis P, Macura KJ, Simopoulos DN, Carter HB, Gorin MA. Active Surveillance of Grade Group 1 Prostate Cancer: Long-term Outcomes from a Large Prospective Cohort. Eur Urol. 2020 Jun;77(6):675-682. doi: 10.1016/j.eururo.2019.12.017. Epub 2020 Jan 7.
PubMed 31918957George AK, Miocinovic R, Patel AR, Lomas DJ, Correa AF, Chen DYT, Rastinehad AR, Schwartz MJ, Sidana A, Stensland KD, Helfand BT, Gahan JC, Meng X, Yu A, Brisbane WG, Vourganti S, Barqawi AB, Uchio EM, Wysock JS, Polascik TJ, McClure TD, Fainberg J, Coleman JA. Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-risk Prostate Cancer: Results from the PRESERVE Trial. Eur Urol. 2026 Jan;89(1):57-68. doi: 10.1016/j.eururo.2025.06.003. Epub 2025 Jul 19.
PubMed 40685282Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18.
PubMed 30898406Delongchamps NB, Peltier A, Potiron E, Bladou F, Diamand R, Messas A, Roche JB, Robert G, Hoepffner JL, Piechaud T, Anract J, Velthoven RV. Targeted microwave ablation of localised prostate cancer (VIOLETTE trial): a prospective multicentre study. BJU Int. 2026 Jun;137(6):1032-1039. doi: 10.1111/bju.70220. Epub 2026 Mar 11.
PubMed 41810596van den Bos W, Scheltema MJ, Siriwardana AR, Kalsbeek AMF, Thompson JE, Ting F, Bohm M, Haynes AM, Shnier R, Delprado W, Stricker PD. Focal irreversible electroporation as primary treatment for localized prostate cancer. BJU Int. 2018 May;121(5):716-724. doi: 10.1111/bju.13983. Epub 2017 Sep 4.
PubMed 28796935Shah TT, Peters M, Eldred-Evans D, Miah S, Yap T, Faure-Walker NA, Hosking-Jervis F, Thomas B, Dudderidge T, Hindley RG, McCracken S, Greene D, Nigam R, Valerio M, Minhas S, Winkler M, Arya M, Ahmed HU. Early-Medium-Term Outcomes of Primary Focal Cryotherapy to Treat Nonmetastatic Clinically Significant Prostate Cancer from a Prospective Multicentre Registry. Eur Urol. 2019 Jul;76(1):98-105. doi: 10.1016/j.eururo.2018.12.030. Epub 2019 Jan 9.
PubMed 30638633Stabile A, Orczyk C, Hosking-Jervis F, Giganti F, Arya M, Hindley RG, Dickinson L, Allen C, Punwani S, Jameson C, Freeman A, McCartan N, Montorsi F, Briganti A, Ahmed HU, Emberton M, Moore CM. Medium-term oncological outcomes in a large cohort of men treated with either focal or hemi-ablation using high-intensity focused ultrasonography for primary localized prostate cancer. BJU Int. 2019 Sep;124(3):431-440. doi: 10.1111/bju.14710. Epub 2019 Mar 18.
PubMed 30753756Hong Kong Cancer Statistics. Prostate Cancer Factsheet 2021. Hong Kong Cancer Registry. Available at: https://www3.ha.org.hk/cancereg/pdf/factsheet/2021/prostate_.pdf. Accessed May 5, 2026.
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Emmett L, Buteau J, Papa N, Moon D, Thompson J, Roberts MJ, Rasiah K, Pattison DA, Yaxley J, Thomas P, Hutton AC, Agrawal S, Amin A, Blazevski A, Chalasani V, Ho B, Nguyen A, Liu V, Lee J, Sheehan-Dare G, Kooner R, Coughlin G, Chan L, Cusick T, Namdarian B, Kapoor J, Alghazo O, Woo HH, Lawrentschuk N, Murphy D, Hofman MS, Stricker P. The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study. Eur Urol. 2021 Dec;80(6):682-689. doi: 10.1016/j.eururo.2021.08.002. Epub 2021 Aug 28.
PubMed 34465492Hoffmann MA, Muller-Hubenthal J, Rosar F, Fischer N, von Eyben FE, Buchholz HG, Wieler HJ, Schreckenberger M. Primary Staging of Prostate Cancer Patients with [18F]PSMA-1007 PET/CT Compared with [68Ga]Ga-PSMA-11 PET/CT. J Clin Med. 2022 Aug 29;11(17):5064. doi: 10.3390/jcm11175064.
PubMed 36078994Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
PubMed 29552975Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
PubMed 28110982
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seeing the Unseen: ¹⁸F-PSMA-1007 PET-CT-Directed Focal Therapy for MRI-Invisible Prostate Cancer (The FOCUS-PSMA Study)
- ClinicalTrials.gov ID
- NCT07788625
- Acronym / sponsor ID
- FOCUS-PSMA / UW 26-323
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 23 Aug 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multi-centre, single-arm Phase II trial conducted at Queen Mary Hospital and Princess Margaret Hospital, Hong Kong. The study adheres to the Declaration of Helsinki and ICH-GCP guidelines, with ethics approval obtained prior to initiation. Eligible patients are men aged ≥50 years, life expectancy >10 years, with histologically confirmed localized prostate cancer (ISUP Grade Group 2 or 3), at least one csPCa focus identified on systematic biopsy that is MRI-invisible (PI-RADS v2.1 score 1-2 in the corresponding region), total of 1-2 discrete cancer foci, PSA <20 ng/mL, and organ-confined disease. Exclusion criteria include prior prostate cancer treatment, pelvic radiotherapy, contraindications to MRI or PSMA PET-CT, and uncorrectable coagulopathy.
Enrolled patients undergo a dedicated pelvis-only ¹⁸F-PSMA-1007 PET-CT within 4 weeks of enrolment. No fasting is required; activity is weight-based. After a 90-minute uptake period, low-dose non-contrast CT and PET imaging of the pelvis are acquired. Iterative reconstruction optimised for small lesion detection is applied. A PRIMARY-adapted five-point PET-score system (1 to 5) is used; focal uptake scoring 3, 4, or 5 defines a PET-positive lesion. Only patients with a PET-positive lesion anatomically correlated with the MRI-invisible biopsy-positive location proceed to focal therapy.
Focal therapy is performed under general or spinal anaesthesia. 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 the ablative modality based on tumour location and constraints from the following: targeted microwave ablation (TMA) using the TATO3® needle; high-intensity focused ultrasound (HIFU) using the Sonablate® system; or irreversible electroporation (IRE) using the NanoKnife® or PoriNova® systems. Treatment is transperineal, with a 5-10 mm intraprostatic margin around the PET-avid and any concurrent MRI-visible lesions, while maintaining a ≥5 mm safety distance from sphincter, rectum, and neurovascular bundles.
Follow-up includes PSA, adverse events, and validated questionnaires (IPSS, IIEF-5, EPIC-26) at month 3 and month 6. At month 6, a repeat mpMRI and transperineal MRI/ultrasound fusion biopsy (3-4 cores per treated area plus a 12-core systematic template) are performed. Pathology is read by dedicated uropathologists with ISUP Grade Group reporting per core and per lesion. Primary outcome: per-patient absence of csPCa (≥ Grade Group 2) on targeted biopsy of all treated zones at 6 months. Secondary outcomes: any cancer in treated zones, out-of-field recurrence, PSA kinetics, functional score changes, adverse events (Clavien-Dindo), quality of life, PET positivity proportion among enrolled patients, and technical success of PET/US fusion.
Sample size uses A'Hern's single-stage phase II design. With an assumed true in-field success rate (p₁) of 0.88 and an unacceptable threshold (p₀) of 0.73, one-sided α=0.05, power=0.80, the critical value is 34 successes out of 40 treated patients. Accounting for a 10% loss to follow-up/biopsy, 45 treated patients are required. Estimating that 75% of enrolled MRI-invisible csPCa patients will have a PET-avid lesion, a total of 60 patients will be enrolled. Recruitment over 24 months is feasible across the two centres, each performing ~200 MRI-guided biopsies annually, with ~15% revealing MRI-invisible csPCa. The primary analysis will be performed on the protocol population; the proportion achieving the primary endpoint will be reported with an exact 95% confidence interval. Secondary endpoints will be analysed using paired t-tests or Wilcoxon signed-rank tests for continuous variables, and McNemar or chi-square tests for categorical variables, with p<0.05 considered significant. SPSS will be used.
Data will be handled in accordance with Hospital Authority policies. Personal data will be coded, stored in locked cabinets and password-protected servers with restricted access, and retained for 10 years post-completion before destruction. Patients who are PET-negative will be managed per institutional standard, with their data collected for secondary analyses. The study is funded by The University of Hong Kong, with consumables for IRE and TMA provided free of charge by Zhejiang CuraWay Medical Technology Co., Ltd. and Chindex Hong Kong Limited, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-Directed Focal Therapy | Experimental | Procedure: Focal Therapy for Prostate CancerPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focal Therapy for Prostate CancerAlso: Targeted Microwave Ablation, High-Intensity Focused Ultrasound, Irreversible Electroporation, TMAFocal 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. | Procedure or surgery | PET-Directed Focal Therapy |
Primary outcome
Absence of clinically significant prostate cancer in treated zones at 6 months
Time frame: At 6 months post-treatment
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).
9 secondary outcomes
Per-lesion absence of csPCa at 6 months
Time frame: At 6 months post-treatment
Any prostate cancer in treated zones at 6 months
Time frame: At 6 months post-treatment
Out-of-field recurrence at 6 months
Time frame: At 6 months post-treatment
Change in serum PSA from baseline to 6 months
Time frame: Baseline to 6 months post-treatment
Proportion of PET-positive cases among MRI-invisible csPCa
Time frame: At baseline (PET-CT)
Change in International Prostate Symptom Score (IPSS)
Time frame: Baseline to 3 months and 6 months post-treatment
Adverse events
Time frame: Intraoperative and up to 6 months post-treatment
Change in International Index of Erectile Function-5 (IIEF-5)
Time frame: Baseline to 3 months and 6 months post-treatment
Change in EPIC-26 urinary continence domain score
Time frame: Baseline to 3 months and 6 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 31918957Tosoian JJ, Mamawala M, Epstein JI, Landis P, Macura KJ, Simopoulos DN, Carter HB, Gorin MA. Active Surveillance of Grade Group 1 Prostate Cancer: Long-term Outcomes from a Large Prospective Cohort. Eur Urol. 2020 Jun;77(6):675-682. doi: 10.1016/j.eururo.2019.12.017. Epub 2020 Jan 7.
- Background: PubMed 40685282George AK, Miocinovic R, Patel AR, Lomas DJ, Correa AF, Chen DYT, Rastinehad AR, Schwartz MJ, Sidana A, Stensland KD, Helfand BT, Gahan JC, Meng X, Yu A, Brisbane WG, Vourganti S, Barqawi AB, Uchio EM, Wysock JS, Polascik TJ, McClure TD, Fainberg J, Coleman JA. Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-risk Prostate Cancer: Results from the PRESERVE Trial. Eur Urol. 2026 Jan;89(1):57-68. doi: 10.1016/j.eururo.2025.06.003. Epub 2025 Jul 19.
- Background: PubMed 30898406Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18.
- Background: PubMed 41810596Delongchamps NB, Peltier A, Potiron E, Bladou F, Diamand R, Messas A, Roche JB, Robert G, Hoepffner JL, Piechaud T, Anract J, Velthoven RV. Targeted microwave ablation of localised prostate cancer (VIOLETTE trial): a prospective multicentre study. BJU Int. 2026 Jun;137(6):1032-1039. doi: 10.1111/bju.70220. Epub 2026 Mar 11.
- Background: PubMed 28796935van den Bos W, Scheltema MJ, Siriwardana AR, Kalsbeek AMF, Thompson JE, Ting F, Bohm M, Haynes AM, Shnier R, Delprado W, Stricker PD. Focal irreversible electroporation as primary treatment for localized prostate cancer. BJU Int. 2018 May;121(5):716-724. doi: 10.1111/bju.13983. Epub 2017 Sep 4.
- Background: PubMed 30638633Shah TT, Peters M, Eldred-Evans D, Miah S, Yap T, Faure-Walker NA, Hosking-Jervis F, Thomas B, Dudderidge T, Hindley RG, McCracken S, Greene D, Nigam R, Valerio M, Minhas S, Winkler M, Arya M, Ahmed HU. Early-Medium-Term Outcomes of Primary Focal Cryotherapy to Treat Nonmetastatic Clinically Significant Prostate Cancer from a Prospective Multicentre Registry. Eur Urol. 2019 Jul;76(1):98-105. doi: 10.1016/j.eururo.2018.12.030. Epub 2019 Jan 9.
- Background: PubMed 30753756Stabile A, Orczyk C, Hosking-Jervis F, Giganti F, Arya M, Hindley RG, Dickinson L, Allen C, Punwani S, Jameson C, Freeman A, McCartan N, Montorsi F, Briganti A, Ahmed HU, Emberton M, Moore CM. Medium-term oncological outcomes in a large cohort of men treated with either focal or hemi-ablation using high-intensity focused ultrasonography for primary localized prostate cancer. BJU Int. 2019 Sep;124(3):431-440. doi: 10.1111/bju.14710. Epub 2019 Mar 18.
- BackgroundHong Kong Cancer Statistics. Prostate Cancer Factsheet 2021. Hong Kong Cancer Registry. Available at: https://www3.ha.org.hk/cancereg/pdf/factsheet/2021/prostate_.pdf. Accessed May 5, 2026.
- Background: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 34465492Emmett L, Buteau J, Papa N, Moon D, Thompson J, Roberts MJ, Rasiah K, Pattison DA, Yaxley J, Thomas P, Hutton AC, Agrawal S, Amin A, Blazevski A, Chalasani V, Ho B, Nguyen A, Liu V, Lee J, Sheehan-Dare G, Kooner R, Coughlin G, Chan L, Cusick T, Namdarian B, Kapoor J, Alghazo O, Woo HH, Lawrentschuk N, Murphy D, Hofman MS, Stricker P. The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study. Eur Urol. 2021 Dec;80(6):682-689. doi: 10.1016/j.eururo.2021.08.002. Epub 2021 Aug 28.
- Background: PubMed 36078994Hoffmann MA, Muller-Hubenthal J, Rosar F, Fischer N, von Eyben FE, Buchholz HG, Wieler HJ, Schreckenberger M. Primary Staging of Prostate Cancer Patients with [18F]PSMA-1007 PET/CT Compared with [68Ga]Ga-PSMA-11 PET/CT. J Clin Med. 2022 Aug 29;11(17):5064. doi: 10.3390/jcm11175064.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal Therapy for Prostate Cancer in people with Prostate Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM (+852 2255 4852, jslleung@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of clinically significant prostate cancer in treated zones at 6 months (time frame: At 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788625, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.