Microwave treatment for enlarged prostate
3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia
NA · Chinese University of Hong Kong · NCT05443451
This study is testing a microwave treatment to see if it can help men with enlarged prostates feel better by reducing their symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05443451 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the use of 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men suffering from symptomatic benign prostatic hyperplasia (BPH). It is a prospective, single-center, open-label trial involving 12 patients who meet specific inclusion criteria. Participants will undergo microwave ablation to reduce prostate size and will be monitored for safety and efficacy over a 6-month follow-up period.
Who should consider this trial
Good fit: Ideal candidates are men over 50 years old with symptomatic BPH and specific prostate size and urinary flow rate criteria.
Not a fit: Patients with significant intravesical median lobe hyperplasia or a history of prostate cancer may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a minimally invasive option for men with BPH, potentially improving urinary symptoms and quality of life.
How similar studies have performed: While this approach is relatively novel, similar microwave ablation techniques have shown promise in other studies for treating BPH.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Peter Ka-Fung CHIU, FRCS, PhD — Chinese University of Hong Kong
- Study coordinator: Peter Ka-Fung CHIU, FRCS, PhD
- Email: peterchiu@surgery.cuhk.eud.hk
- Phone: 3505-2625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Hyperplasia