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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation

• Registration Number: NCT06262633
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

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 Timeline

• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-16
• Status Verified: 2024-03
• Study Start: 2024-03-15
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2026-04-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 103

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peter Ka-Fung CHIU; 🇭🇰 Sha Tin, Hong Kong