Prostate CancerNCT06262633

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

A study testing Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation in people with Prostate Cancer, run by Chinese 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

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 45 to 75 years, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 1 siteHong Kong
Study dates: 15 Mar 2024to 30 Jun 2026
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 45 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Show all 15Show fewer

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.

Trial locations and contacts

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

Peter Ka-Fung CHIU, PhD,MBChB contact

35052625

peterchiu@surgery.cuhk.edu.hk

Hong Kong1 site, 1 recruiting

Peter Ka-Fung CHIU
Shatin
Peter Ka-Fung CHIU, PhD,MBChB, 35052625, peterchiu@surgery.cuhk.edu.hk
Recruiting

Other trials in Hong Kong

About this study

Official title: A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer Using Organ Based Tracking (OBT) Navigation

Read the detailed description

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: Prostate Cancer
Being tested: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06262633
Study group	Role	What they receive
Targeted Microwave Ablation (TMA)	Experimental	Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation Receives: Device: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation

What is being measured

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

The oncological control of prostate cancer
Any cancer detected on biopsy of each ablated area
Measured: At 6 months after treatment

Secondary outcomes (13)

Cancer detection on biopsy of each ablated MRI visible lesion
Cancer detection on biopsy of each ablated MRI visible lesion
Measured: At 6 months after treatment
Cancer detection on biopsy of each ablated MRI invisible lesion
Cancer detection on biopsy of each ablated MRI invisible lesion
Measured: At 6 months after treatment
Gleason 4 or 5 cancer detected on biopsy of ablated area
The higher the Gleason score, the higher grade the prostate cancer
Measured: At 6 months after treatment
Out-of-field recurrence: Any cancer outside treated area on systematic biopsy
Out-of-field recurrence: Any cancer outside treated area on systematic biopsy
Measured: At 6 months after treatment
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Complications of treatment using Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: At 3 Month, 6 Month and 1 year
PSA change
PSA change after treatment
Measured: At baseline, 3 Month and 6 Month and 12 Month
Urinary Symptoms after treatment
Urinary symptoms measured by IPSS score, score ranging from 0-35 (the higher the worse)
Measured: At baseline, 3 Month, 6 Month and 12 Month
Sexual side effects after treatment
Sexual side effects, up to 1 year, measured by IIEF-5 score (ranging from 1-25), the lower the worse
Measured: At baseline, 3 Month, 6 Month and 12 Month
Continence side effects after treatment
Continence side effects, up to 1 year, measured by EPIC-26 questionnaire, the higher score the lower score the worse
Measured: At baseline, 3 Month, 6 Month and 12 Month
Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity
Rectal toxicity of treatment using Common Terminology Criteria for Adverse Events
Measured: At baseline, 3 Month, 6 Month and 12 Month
Quality of life measured by ED-5Q-5Lquestionnaire
Quality of life measured by ED-5Q-5L questionnaire, the higher the score the better in quality of life
Measured: At baseline, 3 Month, 6 Month and 12 Month
Quality of life in patients with prostate cancer measured by EPIC-26
Quality of life in patients with prostate cancer measured by EPIC-26 range 0-100, the higher score the better the quality of life
Measured: At baseline, 3 Month, 6 Month and 12 Month
Quality of life measured by QLQ-C30,
Quality of life measured by QLQ-C30, score 0-100, the higher the score the better in quality of life
Measured: At baseline, 3 Month, 6 Month and 12 Month

Timeline

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

15 Mar 202430 Jun 2026

First posted16 Feb 2024
Study start15 Mar 2024
Primary completion30 Apr 2026 (estimated)
Study completion30 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)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 Chinese 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: 103 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06262633
Sponsor's protocol ID: CRE-2023.079
Status last verified: May 2025
First submitted: 21 Jan 2024
Last updated: 6 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31493960
Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019 Apr;10(2):63-89. doi: 10.14740/wjon1191. Epub 2019 Apr 20.
PubMed 31068988
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.
PubMed 30753756
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.
PubMed 24053685
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
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.
PubMed 34260598
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.
PubMed 35835844
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.
PubMed 30898406

Interested in taking part?

Peter Ka-Fung CHIU, PhD,MBChB

35052625

peterchiu@surgery.cuhk.edu.hk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer Using Organ Based Tracking (OBT) Navigation
ClinicalTrials.gov ID: NCT06262633
Acronym / sponsor ID: CRE-2023.079
Conditions: Prostate Cancer
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 103 participants (estimated)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Study start: 15 Mar 2024 (actual)
Primary completion: 30 Apr 2026 (estimated)
Study completion: 30 Jun 2026 (estimated)
First posted: 16 Feb 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Targeted Microwave Ablation (TMA)	Experimental	Device: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigationTargeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation

Who may qualify

Ages: 45 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (15 listed)

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

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

Primary outcome

The oncological control of prostate cancer
Time frame: At 6 months after treatment
Any cancer detected on biopsy of each ablated area

13 secondary outcomes

Cancer detection on biopsy of each ablated MRI visible lesion
Time frame: At 6 months after treatment
Cancer detection on biopsy of each ablated MRI invisible lesion
Time frame: At 6 months after treatment
Gleason 4 or 5 cancer detected on biopsy of ablated area
Time frame: At 6 months after treatment
Out-of-field recurrence: Any cancer outside treated area on systematic biopsy
Time frame: At 6 months after treatment
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: At 3 Month, 6 Month and 1 year
PSA change
Time frame: At baseline, 3 Month and 6 Month and 12 Month
Urinary Symptoms after treatment
Time frame: At baseline, 3 Month, 6 Month and 12 Month
Sexual side effects after treatment
Time frame: At baseline, 3 Month, 6 Month and 12 Month
Continence side effects after treatment
Time frame: At baseline, 3 Month, 6 Month and 12 Month
Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity
Time frame: At baseline, 3 Month, 6 Month and 12 Month
Quality of life measured by ED-5Q-5Lquestionnaire
Time frame: At baseline, 3 Month, 6 Month and 12 Month
Quality of life in patients with prostate cancer measured by EPIC-26
Time frame: At baseline, 3 Month, 6 Month and 12 Month
Quality of life measured by QLQ-C30,
Time frame: At baseline, 3 Month, 6 Month and 12 Month

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 6 May 2025.
Background: PubMed 31493960Culp 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.
Background: PubMed 31068988Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019 Apr;10(2):63-89. doi: 10.14740/wjon1191. Epub 2019 Apr 20.
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.
Background: PubMed 24053685Durand 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.
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 34260598Barry 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.
Background: PubMed 35835844Chiu 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.
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.
Individual participant dataSharing planned: No

Related trials for Prostate Cancer

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingPhase 2
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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.

Peter Ka-Fung CHIU, PhD,MBChB contact

35052625

peterchiu@surgery.cuhk.edu.hk

Peter Ka-Fung CHIU, PhD,MBChB principal investigator

Chinese University of Hong Kong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 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 6 May 2025. 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 Peter Ka-Fung CHIU, PhD,MBChB (35052625, peterchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The oncological control of prostate cancer (time frame: At 6 months after 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 NCT06262633, which also lists 8 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 6 May 2025.