Clinical trial NCT06262633: A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer
Official title: A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer Using Organ Based Tracking (OBT) Navigation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 103
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The oncological control of prostate cancer
timeFrame: At 6 months after treatment
Secondary outcomes:
measure: Cancer detection on biopsy of each ablated MRI visible lesion
timeFrame: At 6 months after treatment
measure: Cancer detection on biopsy of each ablated MRI invisible lesion
timeFrame: At 6 months after treatment
measure: Gleason 4 or 5 cancer detected on biopsy of ablated area
timeFrame: At 6 months after treatment
measure: Out-of-field recurrence: Any cancer outside treated area on systematic biopsy
timeFrame: At 6 months after treatment
measure: Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: At 3 Month, 6 Month and 1 year
measure: PSA change
timeFrame: At baseline, 3 Month and 6 Month and 12 Month
measure: Urinary Symptoms after treatment
timeFrame: At baseline, 3 Month, 6 Month and 12 Month
measure: Sexual side effects after treatment
timeFrame: At baseline, 3 Month, 6 Month and 12 Month
measure: Continence side effects after treatment
timeFrame: At baseline, 3 Month, 6 Month and 12 Month
measure: Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity
timeFrame: At baseline, 3 Month, 6 Month and 12 Month
measure: Quality of life measured by ED-5Q-5Lquestionnaire
timeFrame: At baseline, 3 Month, 6 Month and 12 Month
measure: Quality of life in patients with prostate cancer measured by EPIC-26
timeFrame: At baseline, 3 Month, 6 Month and 12 Month
measure: Quality of life measured by QLQ-C30,
timeFrame: At baseline, 3 Month, 6 Month and 12 Month
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Peter Ka-Fung CHIU
Study officials:
affiliation: Chinese University of Hong Kong
name: Peter Ka-Fung CHIU, PhD,MBChB
role: PRINCIPAL_INVESTIGATOR
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