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

March 18, 2024 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

103

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 Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Targeted Microwave Ablation (TMA)
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
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.

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

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 Ka-Fung CHIU, PhD,MBChB, 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)

March 15, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2023.079

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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