Microwave Needle Thermoablation for Treatment of Localized Prostate Cancer

May 3, 2025 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital, Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients with bladder pathology including bladder stone and bladder cancer
  • Patients with urethral stricture
  • Patients with neurogenic bladder and/or sphincter abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microwave needle thermoablation of prostate cancer
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.
Device: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Per-patient analysis of any cancer detected on biopsy of any ablated areas
Time Frame: At 6 months after treatment
Per-patient analysis of any cancer detected on biopsy of any ablated areas
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 visible lesion
At 6 months after treatment
Cancer detection on biopsy of each ablated MRI invisible lesion
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 1 year
Complications of treatment using Common Terminology Criteria for Adverse Events (CTCAE) v5.0
1 year
Dimension of necrosis area on MRI
Time Frame: At 1 week
Dimension of necrosis area on MRI
At 1 week
PSA change
Time Frame: At baseline, 4 weeks, 3 months, 6 months and 12 months
PSA change after treatment
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
Urinary symptoms measured by IPSS score, score ranging from 0-35 (the higher the worse)
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
Sexual side effects, up to 1 year, measured by IIEF-5 score (ranging from 1-25), the lower the worse
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
Quality of life in patients with prostate cancer measured by EPIC-26, range 0-100, the higher score the better the quality of life
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
Rectal side effects measured by CTCAE rectal toxicity, Grade 1-5 for any rectal toxicity, the higher the score the more severe the toxicity
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
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
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
Quality of life measured by QLQ-C30, score 0-100, the higher the score the better in quality of life
At baseline, 4 weeks, 3 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Peter KF Chiu, MBChB,FRCSEd, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2019

Primary Completion (Actual)

February 16, 2023

Study Completion (Actual)

April 11, 2023

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (Actual)

October 3, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE 2019.347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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