A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer

NCT06262633 | Recruiting

• 1 other identifier: CRE-2023.079
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The oncological control of prostate cancer

  Any cancer detected on biopsy of each ablated area

  At 6 months after treatment

Secondary Outcomes (13)

• Cancer detection on biopsy of each ablated MRI visible lesion

  At 6 months after treatment

• Cancer detection on biopsy of each ablated MRI invisible lesion

  At 6 months after treatment

• Gleason 4 or 5 cancer detected on biopsy of ablated area

  At 6 months after treatment

• Out-of-field recurrence: Any cancer outside treated area on systematic biopsy

  At 6 months after treatment

• Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  At 3 Month, 6 Month and 1 year

Study Arms (1)

Targeted Microwave Ablation (TMA)

EXPERIMENTAL

Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation

Device: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation

Interventions

Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation DEVICE

Targeted microwave ablation (TMA) is a novel treatment developed for focal treatment of prostate cancer, and it is applied with precise navigation guidance under the organ-based tracking (OBT) mechanism.

Targeted Microwave Ablation (TMA)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged between 45 - 75 years
• Life expectancy \> 10 years upon recruitment
• Able to understand the trial and can provide informed and written consent, dated and signed before the enrollment and before any exam required by the trial
• Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
• Organ-confined prostate cancer on MRI
• PSA \< 20 ng/mL
• MRI visible lesion present and size ≤15mm, with targeted biopsy showing:
• ISUP grade group 2 or 3, or
• ISUP grade group 1 with tumor size ≥10mm

You may not qualify if:

• Patients not fit for general or spinal anaesthesia
• Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of \<50 ml/min)
• Patients with coagulopathy that cannot be corrected
• Patients on anticoagulants or antiplatelets that cannot be stopped (Low dose Aspirin, e.g. 80-100mg, is acceptable and no need to stop before or during TMA treatment)
• Patients with previous treatment of prostate cancer
• Patients with prior pelvic radiotherapy for prostate cancer or other cancer
• Patients with maximal length of target lesion \>15mm
• Patients with MRI-visible or invisible lesion within 10mm from rectum or 10mm from sphincter on MRI
• Patients with \>2 areas (MRI-visible or invisible) of prostate cancer
• Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
• Patients with systematic cores showing any Gleason 4 pattern PCa which are not adjacent to the target lesions (1 core of pure Gleason 3 pattern PCa on systematic cores in contralateral lobe is acceptable)
• Patients with definite cT3 or above disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable)
• Patients with bladder pathology including bladder stone and bladder cancer
• Patients with known urethral stricture
• Patient with a suspected COVID-19 disease or an active SARS-CoV-2 infection.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Peter Ka-Fung CHIU

Shatin, Hong Kong

RECRUITING

Related Publications (8)

• Culp MB, Soerjomataram I, Efstathiou JA, Bray F, Jemal A. Recent Global Patterns in Prostate Cancer Incidence and Mortality Rates. Eur Urol. 2020 Jan;77(1):38-52. doi: 10.1016/j.eururo.2019.08.005. Epub 2019 Sep 5.

  PMID: 31493960 BACKGROUND

• Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019 Apr;10(2):63-89. doi: 10.14740/wjon1191. Epub 2019 Apr 20.

  PMID: 31068988 BACKGROUND

• Stabile 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.

  PMID: 30753756 BACKGROUND

• Durand M, Barret E, Galiano M, Rozet F, Sanchez-Salas R, Ahallal Y, Macek P, Gaya JM, Cerruti J, Devilliers H, Loeffler J, Amiel J, Vallancien G, Cathelineau X. Focal cryoablation: a treatment option for unilateral low-risk prostate cancer. BJU Int. 2014 Jan;113(1):56-64. doi: 10.1111/bju.12370. Epub 2013 Oct 31.

  PMID: 24053685 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

• Barry Delongchamps N, Schull A, Anract J, Abecassis JP, Zerbib M, Sibony M, Jilet L, Abdoul H, Goffin V, Peyromaure M. Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial. PLoS One. 2021 Jul 14;16(7):e0252040. doi: 10.1371/journal.pone.0252040. eCollection 2021.

  PMID: 34260598 BACKGROUND

• Chiu PK, Chan CH, Yee CH, Lau SY, Teoh JY, Wong HF, Lo KL, Yuen TY, Hung HY, Cho CC, Ng CF. Transperineal Targeted Microwave Ablation (TMA) of localized prostate cancer guided by MRI-Ultrasound fusion and organ-based tracking: a pilot study. Prostate Cancer Prostatic Dis. 2023 Dec;26(4):736-742. doi: 10.1038/s41391-022-00577-8. Epub 2022 Jul 14.

  PMID: 35835844 BACKGROUND

• Turkbey 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.

  PMID: 30898406 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Ka-Fung CHIU, PhD,MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Ka-Fung CHIU, PhD,MBChB

CONTACT

35052625; peterchiu@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 16, 2024
• Study Start: March 15, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)