Prostate CancerNCT04113811
Microwave Needle Thermoablation for Treatment of Localized Prostate Cancer
A study testing Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France) in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the surrounding organs like rectum and… 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?
- Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Oct 2019to 11 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
- Organ-confined prostate cancer on MRI
- PSA < 20 ng/mL
- At least 1 MRI visible lesion present and size ≤15mm, and Targeted biopsy showing Gleason score 6 (with cancer core length ≥6mm) or Gleason score 7 (3+4 or 4+3), With or without positive Systematic biopsy (out of 24 systematic cores) away from MRI visible target showing Gleason 6 cancer
Who cannot join
- Patients unfit for MRI exam or MR gadolinium contrast
- Patients with previous treatment of prostate 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 >3 areas (MRI-visible or invisible) of prostate cancer
- Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
Show all 9Show fewer
- Patients with bladder pathology including bladder stone and bladder cancer
- Patients with urethral stricture
- Patients with neurogenic bladder and/or sphincter abnormalities
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong
About this study
Official title: Microwave Needle Thermoablation for Treatment of Localized Prostate Cancer Under the Guidance of MRI-Ultrasound Fusion Organbased Tracking: A Phase 2 Trial.
Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the surrounding organs like rectum and bladder. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the target lesion without treating other benign areas, resulting in disease cure in majority of cases with less treatment morbidity. Microwave treatment to the prostate has been performed since more than 20 years ago for benign prostatic hyperplasia and is approved by FDA in United States. It exerts its effect through thermal destruction of prostate tissue. Targeted treatment of localized prostate cancer using microwave needle ablation guided by MRI and Ultrasound imaging has been performed recently and was shown to be safe and effective. Our study aims to assess the effectiveness of this focal therapy in treating localized prostate cancer.
Read the detailed description
Prostate cancer screening with Prostate specific antigen (PSA) has resulted in an increase in the diagnosis of localized prostate cancer. The traditional approach for treating low-risk and intermediate-risk prostate cancer includes definitive treatment with either radical prostatectomy or radiotherapy, both of which are associated with considerable morbidity mainly in the area of genitourinary and bowel complications. Active surveillance is one of the options for early low grade prostate cancers, but about half of these men would convert to radical treatment in 10 years' time. In the case of localized intermediate risk prostate cancer, active surveillance is not a good option as it is associated with inferior oncological outcomes in subsequent radical treatment
Focal therapy for localized prostate cancer is the middle ground between active surveillance and radical treatment like prostatectomy or radiotherapy. Instead of monitoring a tumor to see when it is going to progress, focal therapy ablates the target lesion with the aim to reduce or avoid radical treatment. Although the efficacy of focal therapy appeared to be inferior to radical treatment with higher recurrence rates of 20-50%, repeated focal treatment is feasible and the complication profile of focal therapy was significantly better. A recent publication showed that in men with majority intermediate risk prostate cancer, 5 and 8-year freedom from radical treatment was 91% and 81%. This avoids the majority of patients with localized prostate cancer from receiving a radical treatment with potential complications. A recent consensus panel agreed that focal therapy should be defined as ablation of the dominant or index lesion only .
Numerous energy modalities have been utilized for focal therapy of prostate cancers, including High-intensity focused ultrasound (HIFU), Cryotherapy, Photodynamic therapy (PDT), Focal laser ablation (FLA), irreversible electroporation (IRE), and focal brachytherapy. All of them are still being considered experimental according to the latest international guideline due to inferior oncological outcomes (high recurrence and retreatment rates) and lack of long term data. The targeting mechanisms during focal therapies are largely cognitive after the operator read the MRI, resulting in limited precision and possible over or under-treatment. Under-treatment would result in residual disease and treatment failure, while over-treatment might result in complications similar to that in radical treatment. The limitation of MRI in revealing all significant tumors in the prostate and the inability to treat MRI-invisible tumors using existing focal therapy platforms also contributed to treatment failure. However, there is still a significant amount of focal therapies being performed worldwide due to its lower overall morbidity than radical treatment, feasibility of repeated focal treatment, and feasibility to proceed to radical treatment in treatment-failure cases.
Microwave treatment to prostate, Transurethral microwave therapy (TUMT), has been performed since more than 20 years ago for benign prostatic hyperplasia as an office procedure under local anaesthesia. It has not been used in prostate cancer treatment until recently a group in France conducted a single arm pilot study using organ-based tracking (OBT) MRI-Ultrasound fusion-guided microwave therapy using Koelis system for focal treatment of prostate cancer. (Clinical Trials number: NCT03023345) The treatment was done in 10 patients using microwave needles via transrectal route under general anaesthesia, with the primary outcome of complete necrosis of the index tumour on prostate MRI on day 7. The results were being reported in a conference paper, showing 80% (8/10) cases with complete necrosis of index tumor on day-7 MRI, and 20% (1/5) targeted biopsy of tumor showing residual low grade cancer at 6 months. No adverse event or complication occurred in all 10 cases.
MRI-Ultrasound fusion-guided prostate needle biopsy has been performed transperineally in Prince of Wales Hospital under routine basis. In this study, we plan to investigate oncological outcome of fusion-guided microwave needle therapy using transperineal (TP) approach under general anaesthesia. Most focal therapy modalities treat lesion that can be seen on MRI and confirmed on biopsy. In cases where significant cancer was located only on systematic biopsy but not on MRI, half or whole gland treatment is usually needed. In the microwave needle ablation guided by organ-based tracking (OBT) MRI-Ultrasound fusion using Koelis system, the positive systematic cores that is not visible on MRI can be accurately localized at the time of biopsy using Koelis system and treated subsequently.
- Conditions
- Prostate Cancer
- Being tested
- Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France)
- Keywords
- Prostate cancer, Focal therapy, Microwave ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France)Device
In this study, we plan to investigate oncological outcome of fusion-guided microwave needle therapy using transperineal (TP) approach
| Study group | Role | What they receive |
|---|---|---|
| Microwave needle thermoablation of prostate cancer | Experimental | The treatment will be performed under general anaesthesia or monitored anaesthetic care using the Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France) under Organ-based Tracking® (OBT) mechanism of the Koelis Trinity® machine. Both Koelis Trinity and TATO3 are CE (European Conformity) marked in Europe. A transrectal sideview ultrasound probe is used for real-time imaging and OBT of the prostate. The TATO3® needle is inserted transperineally to the tumor under MRI-Ultrasound fusion OBT guidance with the treatment zone covering the whole tumor. The dominant MRI-visible lesion and up to 1-2 more MRI-visible or invisible lesion will be treated. Receives: Device: Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France) |
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 (14)
Per-patient analysis of any cancer detected on biopsy of any ablated areas
Per-patient analysis of any cancer detected on biopsy of any ablated areas
Measured: At 6 months after treatment
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
Gleason 4 or 5 cancer detected on biopsy of ablated area
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: 1 year
Dimension of necrosis area on MRI
Dimension of necrosis area on MRI
Measured: At 1 week
PSA change
PSA change after treatment
Measured: At baseline, 4 weeks, 3 months, 6 months and 12 months
International Prostate Symptom Score (IPSS) score
Urinary symptoms measured by IPSS score, score ranging from 0-35 (the higher the worse)
Measured: At baseline, 4 weeks, 3 months, 6 months and 12 months
Sexual side effects, up to 1 year, measured by International Index of Erectile Function 5-item version (IIEF-5) score
Sexual side effects, up to 1 year, measured by IIEF-5 score (ranging from 1-25), the lower the worse
Measured: At baseline, 4 weeks, 3 months, 6 months and 12 months
Expanded Prostate cancer Index Composite (EPIC-26) questionnaire
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, 4 weeks, 3 months, 6 months and 12 months
Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity
Rectal side effects measured by CTCAE rectal toxicity, Grade 1-5 for any rectal toxicity, the higher the score the more severe the toxicity
Measured: At baseline, 4 weeks, 3 months, 6 months and 12 months
EQ-5D (EuroQol 5 dimensions) questionnaire
Quality of life measured by ED-5Q questionnaire, with 5 components [Mobility, Self Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression)], and a Visual analogue scale (EQ-VAS) score, the higher the score the better in quality of life
Measured: At baseline, 4 weeks, 3 months, 6 months and 12 months
QLQ-C30 (Quality of life Core 30) questionnaire
Quality of life measured by QLQ-C30, score 0-100, the higher the score the better in quality of life
Measured: At baseline, 4 weeks, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start8 Oct 2019
- Primary completion16 Feb 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- Model description
- This is a single-centre prospective phase 2 trial to investigate the efficacy of Microwave needle thermoablation of prostate cancer using the Biomedical TATO3® (Thermal Ablation Treatments for Oncology 3) ablation system in patients with localized prostate cancer.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHIU Ka Fung Peter, Chinese University of Hong Kong
- Investigators
- Peter KF Chiu, MBChB,FRCSEd, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113811
- Sponsor's protocol ID
- CRE 2019.347
- Status last verified
- May 2025
- First submitted
- 1 Oct 2019
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schroder FH, Hugosson J, Roobol MJ, Tammela TL, Zappa M, Nelen V, Kwiatkowski M, Lujan M, Maattanen L, Lilja H, Denis LJ, Recker F, Paez A, Bangma CH, Carlsson S, Puliti D, Villers A, Rebillard X, Hakama M, Stenman UH, Kujala P, Taari K, Aus G, Huber A, van der Kwast TH, van Schaik RH, de Koning HJ, Moss SM, Auvinen A; ERSPC Investigators. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet. 2014 Dec 6;384(9959):2027-35. doi: 10.1016/S0140-6736(14)60525-0. Epub 2014 Aug 6.
PubMed 25108889Wallis CJ, Herschorn S, Saskin R, Su J, Klotz LH, Chang M, Kulkarni GS, Lee Y, Kodama RT, Narod SA, Nam RK. Complications after radical prostatectomy or radiotherapy for prostate cancer: results of a population-based, propensity score-matched analysis. Urology. 2015 Mar;85(3):621-7. doi: 10.1016/j.urology.2014.11.037.
PubMed 25733275Nam RK, Cheung P, Herschorn S, Saskin R, Su J, Klotz LH, Chang M, Kulkarni GS, Lee Y, Kodama RT, Narod SA. Incidence of complications other than urinary incontinence or erectile dysfunction after radical prostatectomy or radiotherapy for prostate cancer: a population-based cohort study. Lancet Oncol. 2014 Feb;15(2):223-31. doi: 10.1016/S1470-2045(13)70606-5. Epub 2014 Jan 17.
PubMed 24440474Potosky AL, Davis WW, Hoffman RM, Stanford JL, Stephenson RA, Penson DF, Harlan LC. Five-year outcomes after prostatectomy or radiotherapy for prostate cancer: the prostate cancer outcomes study. J Natl Cancer Inst. 2004 Sep 15;96(18):1358-67. doi: 10.1093/jnci/djh259.
PubMed 15367568Drost FH, Rannikko A, Valdagni R, Pickles T, Kakehi Y, Remmers S, van der Poel HG, Bangma CH, Roobol MJ; PRIAS study group. Can active surveillance really reduce the harms of overdiagnosing prostate cancer? A reflection of real life clinical practice in the PRIAS study. Transl Androl Urol. 2018 Feb;7(1):98-105. doi: 10.21037/tau.2017.12.28.
PubMed 29594024Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.
PubMed 27626136van den Bergh RC, Giannarini G. Prostate cancer: surgery versus observation for localized prostate cancer. Nat Rev Urol. 2014 Jun;11(6):312-3. doi: 10.1038/nrurol.2014.109. Epub 2014 May 13.
PubMed 24818851Sathianathen NJ, Murphy DG, van den Bergh RC, Lawrentschuk N. Gleason pattern 4: active surveillance no more. BJU Int. 2016 Jun;117(6):856-7. doi: 10.1111/bju.13333. Epub 2015 Oct 29. No abstract available.
PubMed 26390094Ahdoot M, Lebastchi AH, Turkbey B, Wood B, Pinto PA. Contemporary treatments in prostate cancer focal therapy. Curr Opin Oncol. 2019 May;31(3):200-206. doi: 10.1097/CCO.0000000000000515.
PubMed 30865133Stabile 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 30753756Nahar B, Parekh DJ. Focal therapy for localized prostate cancer: Where do we stand? Eur Urol Focus. 2020 Mar 15;6(2):208-211. doi: 10.1016/j.euf.2019.04.012. Epub 2019 May 1.
PubMed 31053567Herrmann TR, Gross AJ, Schultheiss D, Kaufmann PM, Jonas U, Burchardt M. Transurethral microwave thermotherapy for the treatment of BPH: still a challenger? World J Urol. 2006 Sep;24(4):389-96. doi: 10.1007/s00345-006-0098-7. Epub 2006 Jun 3.
PubMed 16752156Lerner LB, Thurmond P, Harsch MR, Martinson MS. Office-Based HE-TUMT Costs Less than Medication over Four Years in Treating Benign Prostatic Hyperplasia. Surg Technol Int. 2015 May;26:182-9.
PubMed 26055008Schull A, Abdoul H, Bouazza N, Delongchamps NB. Feasibility and safety of OBTFusion targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: intermediary results of the FOSTINE trial. (NCT03023345). Proceedings of the 11th International Symposium on Focal therapy and Imaging in Prostate and Kidney Cancer 2019.
Le Nobin J, Rosenkrantz AB, Villers A, Orczyk C, Deng FM, Melamed J, Mikheev A, Rusinek H, Taneja SS. Image Guided Focal Therapy for Magnetic Resonance Imaging Visible Prostate Cancer: Defining a 3-Dimensional Treatment Margin Based on Magnetic Resonance Imaging Histology Co-Registration Analysis. J Urol. 2015 Aug;194(2):364-70. doi: 10.1016/j.juro.2015.02.080. Epub 2015 Feb 21.
PubMed 25711199
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Needle Thermoablation for Treatment of Localized Prostate Cancer Under the Guidance of MRI-Ultrasound Fusion Organbased Tracking: A Phase 2 Trial.
- ClinicalTrials.gov ID
- NCT04113811
- Acronym / sponsor ID
- CRE 2019.347
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Focal therapy, Microwave ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 3 Oct 2019 (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.
Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the surrounding organs like rectum and bladder. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the target lesion without treating other benign areas, resulting in disease cure in majority of cases with less treatment morbidity. Microwave treatment to the prostate has been performed since more than 20 years ago for benign prostatic hyperplasia and is approved by FDA in United States. It exerts its effect through thermal destruction of prostate tissue. Targeted treatment of localized prostate cancer using microwave needle ablation guided by MRI and Ultrasound imaging has been performed recently and was shown to be safe and effective. Our study aims to assess the effectiveness of this focal therapy in treating localized prostate cancer.
Detailed description
Prostate cancer screening with Prostate specific antigen (PSA) has resulted in an increase in the diagnosis of localized prostate cancer. The traditional approach for treating low-risk and intermediate-risk prostate cancer includes definitive treatment with either radical prostatectomy or radiotherapy, both of which are associated with considerable morbidity mainly in the area of genitourinary and bowel complications. Active surveillance is one of the options for early low grade prostate cancers, but about half of these men would convert to radical treatment in 10 years' time. In the case of localized intermediate risk prostate cancer, active surveillance is not a good option as it is associated with inferior oncological outcomes in subsequent radical treatment
Focal therapy for localized prostate cancer is the middle ground between active surveillance and radical treatment like prostatectomy or radiotherapy. Instead of monitoring a tumor to see when it is going to progress, focal therapy ablates the target lesion with the aim to reduce or avoid radical treatment. Although the efficacy of focal therapy appeared to be inferior to radical treatment with higher recurrence rates of 20-50%, repeated focal treatment is feasible and the complication profile of focal therapy was significantly better. A recent publication showed that in men with majority intermediate risk prostate cancer, 5 and 8-year freedom from radical treatment was 91% and 81%. This avoids the majority of patients with localized prostate cancer from receiving a radical treatment with potential complications. A recent consensus panel agreed that focal therapy should be defined as ablation of the dominant or index lesion only .
Numerous energy modalities have been utilized for focal therapy of prostate cancers, including High-intensity focused ultrasound (HIFU), Cryotherapy, Photodynamic therapy (PDT), Focal laser ablation (FLA), irreversible electroporation (IRE), and focal brachytherapy. All of them are still being considered experimental according to the latest international guideline due to inferior oncological outcomes (high recurrence and retreatment rates) and lack of long term data. The targeting mechanisms during focal therapies are largely cognitive after the operator read the MRI, resulting in limited precision and possible over or under-treatment. Under-treatment would result in residual disease and treatment failure, while over-treatment might result in complications similar to that in radical treatment. The limitation of MRI in revealing all significant tumors in the prostate and the inability to treat MRI-invisible tumors using existing focal therapy platforms also contributed to treatment failure. However, there is still a significant amount of focal therapies being performed worldwide due to its lower overall morbidity than radical treatment, feasibility of repeated focal treatment, and feasibility to proceed to radical treatment in treatment-failure cases.
Microwave treatment to prostate, Transurethral microwave therapy (TUMT), has been performed since more than 20 years ago for benign prostatic hyperplasia as an office procedure under local anaesthesia. It has not been used in prostate cancer treatment until recently a group in France conducted a single arm pilot study using organ-based tracking (OBT) MRI-Ultrasound fusion-guided microwave therapy using Koelis system for focal treatment of prostate cancer. (Clinical Trials number: NCT03023345) The treatment was done in 10 patients using microwave needles via transrectal route under general anaesthesia, with the primary outcome of complete necrosis of the index tumour on prostate MRI on day 7. The results were being reported in a conference paper, showing 80% (8/10) cases with complete necrosis of index tumor on day-7 MRI, and 20% (1/5) targeted biopsy of tumor showing residual low grade cancer at 6 months. No adverse event or complication occurred in all 10 cases.
MRI-Ultrasound fusion-guided prostate needle biopsy has been performed transperineally in Prince of Wales Hospital under routine basis. In this study, we plan to investigate oncological outcome of fusion-guided microwave needle therapy using transperineal (TP) approach under general anaesthesia. Most focal therapy modalities treat lesion that can be seen on MRI and confirmed on biopsy. In cases where significant cancer was located only on systematic biopsy but not on MRI, half or whole gland treatment is usually needed. In the microwave needle ablation guided by organ-based tracking (OBT) MRI-Ultrasound fusion using Koelis system, the positive systematic cores that is not visible on MRI can be accurately localized at the time of biopsy using Koelis system and treated subsequently.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-centre prospective phase 2 trial to investigate the efficacy of Microwave needle thermoablation of prostate cancer using the Biomedical TATO3® (Thermal Ablation Treatments for Oncology 3) ablation system in patients with localized prostate cancer.
| Arm | Type | Receives |
|---|---|---|
| Microwave needle thermoablation of prostate cancer | Experimental | Device: Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France)The treatment will be performed under general anaesthesia or monitored anaesthetic care using the Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France) under Organ-based Tracking® (OBT) mechanism of the Koelis Trinity® machine. Both Koelis Trinity and TATO3 are CE (European Conformity) marked in Europe. A transrectal sideview ultrasound probe is used for real-time imaging and OBT of the prostate. The TATO3® needle is inserted transperineally to the tumor under MRI-Ultrasound fusion OBT guidance with the treatment zone covering the whole tumor. The dominant MRI-visible lesion and up to 1-2 more MRI-visible or invisible lesion will be treated. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men aged between 45 - 75 years
- Life expectancy > 10 years upon recruitment
- Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
- Organ-confined prostate cancer on MRI
- PSA < 20 ng/mL
Key exclusion criteria (9 listed)
- Patients unfit for MRI exam or MR gadolinium contrast
- Patients with previous treatment of prostate 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 >3 areas (MRI-visible or invisible) 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 |
|---|---|---|
| Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France)In this study, we plan to investigate oncological outcome of fusion-guided microwave needle therapy using transperineal (TP) approach | Device | Microwave needle thermoablation of prostate cancer |
Primary outcome
The oncological control of prostate cancer
Time frame: At 6 months after treatment
Any cancer detected on biopsy of each ablated area
14 secondary outcomes
Per-patient analysis of any cancer detected on biopsy of any ablated areas
Time frame: At 6 months after treatment
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: 1 year
Dimension of necrosis area on MRI
Time frame: At 1 week
PSA change
Time frame: At baseline, 4 weeks, 3 months, 6 months and 12 months
International Prostate Symptom Score (IPSS) score
Time frame: At baseline, 4 weeks, 3 months, 6 months and 12 months
Sexual side effects, up to 1 year, measured by International Index of Erectile Function 5-item version (IIEF-5) score
Time frame: At baseline, 4 weeks, 3 months, 6 months and 12 months
Expanded Prostate cancer Index Composite (EPIC-26) questionnaire
Time frame: At baseline, 4 weeks, 3 months, 6 months and 12 months
Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity
Time frame: At baseline, 4 weeks, 3 months, 6 months and 12 months
EQ-5D (EuroQol 5 dimensions) questionnaire
Time frame: At baseline, 4 weeks, 3 months, 6 months and 12 months
QLQ-C30 (Quality of life Core 30) questionnaire
Time frame: At baseline, 4 weeks, 3 months, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 25108889Schroder FH, Hugosson J, Roobol MJ, Tammela TL, Zappa M, Nelen V, Kwiatkowski M, Lujan M, Maattanen L, Lilja H, Denis LJ, Recker F, Paez A, Bangma CH, Carlsson S, Puliti D, Villers A, Rebillard X, Hakama M, Stenman UH, Kujala P, Taari K, Aus G, Huber A, van der Kwast TH, van Schaik RH, de Koning HJ, Moss SM, Auvinen A; ERSPC Investigators. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet. 2014 Dec 6;384(9959):2027-35. doi: 10.1016/S0140-6736(14)60525-0. Epub 2014 Aug 6.
- Background: PubMed 25733275Wallis CJ, Herschorn S, Saskin R, Su J, Klotz LH, Chang M, Kulkarni GS, Lee Y, Kodama RT, Narod SA, Nam RK. Complications after radical prostatectomy or radiotherapy for prostate cancer: results of a population-based, propensity score-matched analysis. Urology. 2015 Mar;85(3):621-7. doi: 10.1016/j.urology.2014.11.037.
- Background: PubMed 24440474Nam RK, Cheung P, Herschorn S, Saskin R, Su J, Klotz LH, Chang M, Kulkarni GS, Lee Y, Kodama RT, Narod SA. Incidence of complications other than urinary incontinence or erectile dysfunction after radical prostatectomy or radiotherapy for prostate cancer: a population-based cohort study. Lancet Oncol. 2014 Feb;15(2):223-31. doi: 10.1016/S1470-2045(13)70606-5. Epub 2014 Jan 17.
- Background: PubMed 15367568Potosky AL, Davis WW, Hoffman RM, Stanford JL, Stephenson RA, Penson DF, Harlan LC. Five-year outcomes after prostatectomy or radiotherapy for prostate cancer: the prostate cancer outcomes study. J Natl Cancer Inst. 2004 Sep 15;96(18):1358-67. doi: 10.1093/jnci/djh259.
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- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Peter KF Chiu, MBChB,FRCSEd 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?
A study testing Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France) in people with Prostate Cancer, run by Chinese 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 5 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT04113811, which also lists 17 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 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.