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AzTrials

Prostate CancerNCT07792590

Registry for Prostate Cancer Focal Therapy

An observational study of Prostate Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Whole gland therapy (radical prostatectomy and radiotherapy) has been the conventional treatment for localized prostate cancer, but randomized controlled trials have not demonstrated survival benefits compared with watchful waiting or active surveillance. Read more about this study

Who is it for?
Ages 18 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
How many people
200 participants
Where
1 siteHong Kong
Study dates
31 Oct 2025to 28 Feb 2031
Phase
Observational
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients who had undergone focal therapies including but not limited to cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), and irreversible electroporation (IRE) surgeries performed under Department of Surgery, Queen Mary Hospital for prostate cancer will be invited to participate, except patients who are incapable to provide written informed consent. Estimated number of patients fulfilling criteria is 200.

Who may be able to join

  • Patients who have undergone focal therapies for prostate cancer at the Department of Surgery, Queen Mary Hospital
  • Includes but not limited to: cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), and irreversible electroporation (IRE)
  • Willing and able to provide written informed consent

Who cannot join

  • Patients who are incapable to provide written informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM contact

+852 2255 4852

jslleung@hku.hk

Yusra Saleem, BSc contact

+852 2255 4852

yusra@hku.hk

Hong Kong1 site, 1 recruiting
  • Queen Mary Hospital

    Hong Kong, Hong Kong

    Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM, +852 2255 4852, jslleung@hku.hk

    Yusra Saleem, BSc, +852 2255 4852, yusra@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Prospective Database / Registry of Focal Therapy for Prostate Cancer

Whole gland therapy (radical prostatectomy and radiotherapy) has been the conventional treatment for localized prostate cancer, but randomized controlled trials have not demonstrated survival benefits compared with watchful waiting or active surveillance. Whole gland therapy is also associated with significant long-term sequelae including urinary incontinence, erectile dysfunction, irradiation cystitis, and proctitis. Focal therapy has emerged as an alternative treatment modality, yet more data are needed to ensure its safety and efficacy. This is a prospective database/registry study designed to record all pre-operative, intra-operative, and post-operative parameters for patients undergoing focal therapies for prostate cancer, including but not limited to cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), irreversible electroporation (IRE), targeted microwave ablation (TMA). All patients who have undergone focal therapy at the Department of Surgery, Queen Mary Hospital for prostate cancer will be invited to participate, except those incapable of providing written informed consent. The primary outcome is the surgical outcomes (complications and effectiveness) of focal therapies. Secondary outcomes include identification of risk factors for treatment-related complications, provision of a readily available dataset for subsequent research, and identification of the best treatment allocation for prostate cancer patients. An estimated 200 patients will be included, with data collection from study start until 31 March 2030.

Read the detailed description

Background and Rationale

Whole gland therapy (i.e. radical prostatectomy and radiotherapy) has been the conventional treatment for localized prostate cancer for years. However, randomized controlled trials have not shown survival benefits with whole gland therapy comparing with watchful waiting or active surveillance. There is therefore a rising trend of exploring focal therapy for localized prostate cancer as an alternative, as whole gland therapy has significant long-term sequelae, such as urinary incontinence and erectile dysfunction for prostatectomy, and irradiation cystitis and proctitis for radiotherapy. More data are needed to ensure the safety and efficacy of focal therapy.

Study Design

This is a prospective database/registry study to record all pre-operative, intra-operative and post-operative parameters for the following, but not exclusively, focal therapies: cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), and irreversible electroporation (IRE).

Data Collection Parameters

Pre-operative parameters: age, medical comorbidities, prostatic specific antigen (PSA), multi-parametric magnetic resonance imaging (mpMRI) findings, prostate biopsy method and pathology result, Prostate Specific Membrane Antigen (PSMA) scan result (if applicable), sexual and continence function assessment.

Intra-operative parameters: method of anaesthesia, details of operations, post-operative hospital stay, post-operative complications, post-operative pain score.

Post-operative parameters: post-operative PSA, sexual and continence function assessment, mpMRI findings, prostate biopsy result, cancer status, death.

Aim of Study

To determine the effectiveness and safety of focal therapies in treating prostate cancer.

Primary Outcome

The surgical outcomes (complications and effectiveness) of focal therapies.

Secondary Outcomes

To identify the risk factors for treatment related complications

To provide a readily available dataset for subsequent research on focal therapy

To identify the best treatment allocation for prostate cancer patients

Inclusion Criteria and Subject Identification

All patients who had undergone focal therapies including but not limited to cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), and irreversible electroporation (IRE) surgeries performed under Department of Surgery, Queen Mary Hospital for prostate cancer will be invited to participate, except patients who are incapable to provide written informed consent.

Estimated Sample Size

Estimated number of patients fulfilling criteria: 200

Data Collection Period

Study start to 31 March 2030

Statistical Analysis

The study will be analysed with SPSS software using descriptive statistics, t-test and proportional testing. Any hypothesis test result with p<0.05 will be deemed significant.

Data Access and Handling

To protect patient privacy, all research data will be handled in line with Hospital Authority's or Hospital's policy in handling/storage/destruction of patients' medical records. They would be locked in cabinets where the department/ward keep patients' medical records. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information for personal data. Personal data (name, HKID, address and any other personal identifiable information) should not be recorded on the projects' data sheets or electronic files. A study code will be used. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and will be dealt with the same stringent regulations of security according to the hospital policies. The principal investigator/co-investigator will be responsible for the execution of data protection. Only Principal investigator and delegated study staff will have access to the data during and after the study. Collected study data will be kept for 5 years after the completion of the study. After that, study data will be condemned according to Hospital Authority standard of handling privacy data.

Ethical Considerations

There is no major ethical concerns since this is only a review of outcomes and patient data with no new data generated for the study. Principal investigator will ensure only data in need are collected and no sensitive data such as name and patient contact are collected.

Financing and Insurance

No additional financing or insurance requirements necessary.

Declaration

This study complies with the Declaration of Helsinki.

Conditions
Prostate Cancer
Being tested
Focal Therapy for Prostate Cancer
Keywords
Prostate cancer, Focal Therapy, irreversible electroporation, IRE, focal laser therapy, FLA, high-intensity focused ultrasound, HIFU, mpMRI
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 Cryotherapy, High-Intensity Focused Ultrasound, HIFU, Focal Laser Therapy

    Focal ablation for prostate cancer using one of the following modalities: cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), or irreversible electroporation (IRE), targeted microwave ablation (TMA). The specific modality is selected based on clinical indication. Data on pre-operative, intra-operative, and post-operative parameters are collected prospectively in a registry. Primary outcome is surgical outcomes (complications and effectiveness). Secondary outcomes include identification of risk factors for treatment-related complications, provision of a readily available dataset for subsequent research, and identification of the best treatment allocation.

Study groups in NCT07792590
Study groupRoleWhat they receive
Prostate Cancer Focal Therapy RegistryPatients with prostate cancer who have undergone focal therapies including cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), and irreversible electroporation (IRE) at the Department of Surgery, Queen Mary Hospital. Pre-operative, intra-operative, and post-operative parameters are prospectively collected. Primary outcome is surgical outcomes (complications and effectiveness). Secondary outcomes include identification of risk factors for complications, provision of a dataset for subsequent research, and identification of best treatment allocation.
Receives: Procedure: Focal Therapy for Prostate Cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The surgical outcomes of focal therapies.

    Complications and effectiveness of focal therapies for prostate cancer

    Measured: Through study completion, an average of 5 years

Secondary outcomes (3)
  1. Risk factors for treatment-related complications

    Identification of risk factors associated with complications following focal therapy for prostate cancer.

    Measured: Through study completion, an average of 5 years

  2. Pre-operative, intra-operative, and post-operative parameters for subsequent research on focal therapy

    Provision of a readily available dataset of pre-operative parameters (age, medical comorbidities, PSA, mpMRI findings, prostate biopsy method and pathology result, PSMA scan result if applicable, sexual and continence function assessment), intra-operative parameters (method of anaesthesia, details of operations, post-operative hospital stay, post-operative complications, post-operative pain score), and post-operative parameters (post-operative PSA, sexual and continence function assessment, mpMRI findings, prostate biopsy result, cancer status, death) for subsequent research on focal therapy for prostate cancer.

    Measured: Throughout the study data collection period, an average of 5 years

  3. Treatment allocation and outcomes by focal therapy modality

    To identify the best treatment allocation for prostate cancer patients by comparing outcomes (complications, effectiveness, functional outcomes, cancer status) across focal therapy modalities including cryotherapy, high-intensity focused ultrasound (HIFU), focal laser therapy (FLA), and irreversible electroporation (IRE) based on registry data analysis.

    Measured: At data analysis, 2.5 years after the first recruitment of patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start31 Oct 2025
  3. Primary completion30 Nov 2030 (estimated)
  4. Study completion28 Feb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07792590
Sponsor's protocol ID
UW 25-486
Status last verified
Aug 2026
First submitted
21 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van den Bos W, Jurhill RR, de Bruin DM, Savci-Heijink CD, Postema AW, Wagstaff PG, Muller BG, Varkarakis IM, Skolarikos A, Zondervan PJ, Laguna Pes MP, de Reijke TM, de la Rosette JJ. Histopathological Outcomes after Irreversible Electroporation for Prostate Cancer: Results of an Ablate and Resect Study. J Urol. 2016 Aug;196(2):552-9. doi: 10.1016/j.juro.2016.02.2977. Epub 2016 Mar 19.

    PubMed 27004693
  • George 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 40685282
  • Shah 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 30638633
  • Delongchamps 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 41810596
  • Light A, Peters M, Gopalakrishnan A, Mayor N, Cullen E, Boaz RJ, Norris JM, Morris S, Arya M, Tanaka MB, Doherty A, Dudderidge T, Emara A, Emberton M, Grey A, Hindley R, Laniado M, McCraken S, Moore CM, Nigam R, Noureldin M, Orczyk C, Rakauskas A, Simmons L, Virdi J, Withington J, Zakikhani P, Ahmed HU, Shah TT. Oncological Outcomes Following Focal HIFU and Cryotherapy for Treatment of Nonmetastatic Prostate Cancer in the United Kingdom: An Updated Analysis of 3477 Patients from the Prospective HEAT and ICE Registries. Eur Urol. 2026 Jul 10:S0302-2838(26)02169-X. doi: 10.1016/j.eururo.2026.05.007. Online ahead of print.

    PubMed 42431756

Questions about this trial

What is this clinical trial studying?

An observational study of 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 3 inclusion and 1 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 28 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?

The surgical outcomes of focal therapies. (time frame: Through study completion, an average of 5 years). 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 NCT07792590, which also lists 5 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 28 Aug 2026.

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