BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

Launched by CHINESE UNIVERSITY OF HONG KONG · Jun 30, 2022

Keywords

ClinConnect Summary

The BETTY trial is a study looking at a new treatment for men with benign prostatic hyperplasia (BPH), a condition where the prostate gland becomes enlarged, causing urinary problems. This trial is testing a method called 3D-Ultrasound-Guided Transperineal Microwave Needle Ablation, which aims to relieve symptoms by using heat to target the enlarged prostate. The study is currently recruiting men who are over 50 years old, have specific prostate sizes, and experience significant urinary issues.

To be eligible for the trial, participants should have a prostate size between 30-80 cc and a certain level of urinary difficulty, as measured by a symptom score. They also need to be able to handle anesthesia for the procedure. If someone has had certain medical issues, like a history of prostate cancer or specific surgeries, they may not be able to participate. Participants in the trial can expect to undergo the microwave treatment and will be closely monitored throughout the process. This study aims to gather information that could help improve treatment options for men suffering from BPH.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Age over 50 years.
• • Benign prostatic hyperplasia with prostate size 30-80 cc
• • IPSS ≥ 14
• • PSA ≤ 4 ng/mL or PSA \>4 ng/mL with no evidence of suspicious lesion on mpMRI
• • Maximum urine flow rate (Qmax) ≤ 15 mL/s.
• • Post-Void Residual ≤ 150 mL.
• • Patient suitable for IV sedation and/or spinal anaesthesia and/or general anaesthesia and focal microwave ablation.
• • Informed written consent
• Exclusion Criteria:
• • Significant intravesical median lobe hyperplasia.
• • Suspicious lesion on mpMRI prostate
• • History of prostate, bladder or urethral surgery.
• • History of prostate cancer
• • Presence of stones, bladder diverticulum and/or bladder tumor
• • History of long-term indwelling catheter.
• • Urethral stricture
• • Known coagulopathy or on anticoagulant
• • Presence of a pacemaker.
• • Active infection
• • Dysuria due to bladder dysfunction.
• • Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit.
• • Neurological disorders that would impact bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury).
• • Contraindications for mpMRI exam or MR contrast
• • Acute and/or chronic renal failure (GFR \<50 ml/min and serum creatinine \> 1.5 mg/d).
• • Patient currently participating in another interventional clinical trial.