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New treatment option for Prostate Cancer
Official title A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer
ClinicalTrials.gov ID: NCT06262633
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75, men only
You may be able to join if
- Men aged between 45 - 75 years
- Life expectancy \> 10 years upon recruitment
- 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...
- Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
- Organ-confined prostate cancer on MRI
You likely can't join if
- Patients not fit for general or spinal anaesthesia
- Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of \<50 ml/min)
- Patients with coagulopathy that cannot be corrected
- 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...
- Patients with previous treatment of prostate cancer
- Patients with prior pelvic radiotherapy for prostate cancer or other cancer
See the full eligibility criteria
- Men aged between 45 - 75 years
- Life expectancy \> 10 years upon recruitment
- 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
- Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
- Organ-confined prostate cancer on MRI
- PSA \< 20 ng/mL
- 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
- Patients not fit for general or spinal anaesthesia
- Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of \<50 ml/min)
- Patients with coagulopathy that cannot be corrected
- 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)
- Patients with previous treatment of prostate cancer
- Patients with prior pelvic radiotherapy for prostate cancer or other 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 \>2 areas (MRI-visible or invisible) of prostate cancer
- Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
- 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)
- Patients with definite cT3 or above disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable)
- Patients with bladder pathology including bladder stone and bladder cancer
- Patients with known urethral stricture
- Patient with a suspected COVID-19 disease or an active SARS-CoV-2 infection.
The study team makes the final eligibility decision.
Where it's taking place
- Shatin, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shatin, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.