Registry for Prostate Cancer Focal Therapy

NCT07792590 | Recruiting

• 1 other identifier: UW 25-486
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Focal Therapy; irreversible electroporation; IRE; focal laser therapy; FLA; high-intensity focused ultrasound; HIFU; mpMRI

Outcome Measures

Primary Outcomes (1)

• The surgical outcomes of focal therapies.

  Complications and effectiveness of focal therapies for prostate cancer

  Through study completion, an average of 5 years

Secondary Outcomes (3)

• Risk factors for treatment-related complications

  Through study completion, an average of 5 years

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

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

• Treatment allocation and outcomes by focal therapy modality

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

Study Arms (1)

Prostate Cancer Focal Therapy Registry

Patients 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.

Procedure: Focal Therapy for Prostate Cancer

Interventions

Focal Therapy for Prostate Cancer PROCEDURE

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.

Also known as: Cryotherapy, High-Intensity Focused Ultrasound, HIFU, Focal Laser Therapy, FLA, Irreversible Electroporation, IRE

Prostate Cancer Focal Therapy Registry

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Patients who are incapable to provide written informed consent.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

RECRUITING

Related Publications (5)

• 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.

  PMID: 27004693 BACKGROUND

• 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.

  PMID: 40685282 BACKGROUND

• 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.

  PMID: 30638633 BACKGROUND

• 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.

  PMID: 41810596 BACKGROUND

• 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.

  PMID: 42431756 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cryotherapy; Electroporation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Shung Lai John Leung

  The University of Hong Kong, Hospital Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 28, 2026
• Study Start: October 31, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): February 28, 2031
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

HK (1)