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

NCT ID: NCT06262633

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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This is a prospective multi-centre trial in 5 hospitals in 3 countries to investigate the efficacy and complications of targeted Microwave Ablation as a minimally invasive focal therapy for prostate cancer. Men aged 50-75 with PSA \< 20ng/mL and clinically significant prostate cancer with 1-2 MRI lesions ≤15mm and ISUP grade group ≤3 will be recruited. Transperineal targeted Microwave Ablation of the prostate tumor(s) will be done with repeated ablations by a single microwave needle guided by MRI-Ultrasound fusion and organ-based tracking navigation. The primary outcome is any clinically significant prostate cancer detected on biopsy of treated area(s) per patient at 6 months.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Targeted Microwave Ablation (TMA)

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Men aged between 45 - 75 years
2. Life expectancy \> 10 years upon recruitment
3. 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
4. Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
5. Organ-confined prostate cancer on MRI
6. PSA \< 20 ng/mL
7. 1-2 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

Exclusion Criteria

1. Patients not fit for general or spinal anaesthesia
2. Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of \<50 ml/min)
3. Patients with coagulopathy that cannot be corrected
4. 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)
5. Patients with previous treatment of prostate cancer
6. Patients with prior pelvic radiotherapy for prostate cancer or other cancer
7. Patients with maximal length of target lesion \>15mm
8. Patients with MRI-visible or invisible lesion within 10mm from rectum or 10mm from sphincter on MRI
9. . Patients with \>2 areas (MRI-visible or invisible) of prostate cancer
10. Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
11. 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)
12. Patients with definite cT3 or above disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable)
13. Patients with bladder pathology including bladder stone and bladder cancer
14. Patients with known urethral stricture
15. Patient with a suspected COVID-19 disease or an active SARS-CoV-2 infection.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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CHIU Ka Fung Peter

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Ka-Fung CHIU, PhD,MBChB

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Peter Ka-Fung CHIU

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Peter Ka-Fung CHIU, PhD,MBChB

Role: CONTACT

Facility Contacts

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Peter Ka-Fung CHIU, PhD,MBChB

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31493960 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 31068988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30753756 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24053685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30638633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34260598 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35835844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30898406 (View on PubMed)

Other Identifiers

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CRE-2023.079

Identifier Type: -

Identifier Source: org_study_id

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