BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

Prostate Hyperplasia Clinical Trial

Official title:

3D-Ultrasound-Guided Transperineal Microwave Needle Ablation for Men With Symptomatic Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443451
• Other study ID #: CRE 2022.249
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: Peter Ka-Fung CHIU, FRCS, PhD
• Phone: 3505-2625
• Email: peterchiu[@]surgery.cuhk.eud.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).

Description:

This is a prospective, single centre, open-label and non-comparative trial planned on 12 patients. Patients who fit inclusion criteria would be recruited and offered microwave ablation to the enlarged prostate. The patients will be closely followed up to 6 months after treatment with serial assessment on safety and efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH
The procedure will consist of a focal, transperineal, targeted microwave ablation of prostate adenoma. Surgical planning using 3D transrectal ultrasound and real-time monitoring of the ablation would preserve key anatomical landmarks such as the bladder neck, prostatic urethra and verumontanum. The Organ-Based Tracking (OBT®) patented technology would provide a 3D prostate model to facilitate real-time navigation-guided ablation and accurate mapping of treatment zone. The procedure will be conducted under general anaesthesia, spinal anaesthesia, or monitored anaesthetic care / sedation. An average number of one to three microwave ablations per lobe is expected, depending on the size and shape of each prostate. The microwave ablation parameters will be chosen intraoperatively. A urinary catheter may be necessary immediately after the procedure. Patients are planned to be discharged on the same day or the day after when they are fit for discharge.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Koelis

Country where clinical trial is conducted

Hong Kong, 

References & Publications (12)

Barry Delongchamps N, Schull A, Anract J, Abecassis JP, Zerbib M, Sibony M, Jilet L, Abdoul H, Goffin V, Peyromaure M. Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial. PLoS One. 2021 Jul 14;16(7):e0252040. doi: 10.1371/journal.pone.0252040. eCollection 2021. — View Citation

Chiu PK, Lo KL, Teoh JY, Ma SF, Leung CH, Wong HF, Li KM, Sae-Lo K, Kwok SW, Li SY, Yee CH, Hou SM, Ng CF. Sectoral cancer detection and tolerability of freehand transperineal prostate biopsy under local anaesthesia. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):431-438. doi: 10.1038/s41391-020-00293-1. Epub 2020 Sep 30. — View Citation

Chughtai B, Elterman D, Shore N, Gittleman M, Motola J, Pike S, Hermann C, Terrens W, Kohan A, Gonzalez RR, Katz A, Schiff J, Goldfischer E, Grunberger I, Tu LM, Alshak MN, Kaminetzky J. The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial. Urology. 2021 Jul;153:270-276. doi: 10.1016/j.urology.2020.12.022. Epub 2020 Dec 26. — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. — View Citation

Lo KL, Chui KL, Leung CH, Ma SF, Lim K, Ng T, Wong J, Li JKM, Mak SK, Ng CF. Outcomes of transperineal and transrectal ultrasound-guided prostate biopsy. Hong Kong Med J. 2019 Jun;25(3):209-215. doi: 10.12809/hkmj187599. Epub 2019 May 29. — View Citation

Madersbacher S, Lackner J, Brossner C, Rohlich M, Stancik I, Willinger M, Schatzl G; Prostate Study Group of the Austrian Society of Urology. Reoperation, myocardial infarction and mortality after transurethral and open prostatectomy: a nation-wide, long-term analysis of 23,123 cases. Eur Urol. 2005 Apr;47(4):499-504. doi: 10.1016/j.eururo.2004.12.010. Epub 2005 Jan 23. — View Citation

McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19. — View Citation

Ng CF, Yee CH, Chan CK, Wong HM, Chiu PK, Tsu JH, Teoh JY, Ho KL. Bipolar transurethral vapourisation versus monopolar transurethral resection of prostate: a randomised controlled trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):32-34. No abstract available. — View Citation

Raizenne BL, Zheng X, Mao J, Zorn KC, Cho A, Elterman D, Bhojani N, Sedrakyan A, Chughtai B. Real-world data comparing minimally invasive surgeries for benign prostatic hyperplasia. World J Urol. 2022 May;40(5):1185-1193. doi: 10.1007/s00345-021-03926-9. Epub 2022 Feb 2. — View Citation

Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010 Jan;57(1):123-31. doi: 10.1016/j.eururo.2009.09.035. Epub 2009 Sep 19. Erratum In: Eur Urol. 2010 Nov;58(5):801. — View Citation

Yee CH, Wong JH, Chiu PK, Chan CK, Lee WM, Tsu JH, Teoh JY, Ng CF. Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection. Asian J Endosc Surg. 2015 Aug;8(3):316-22. doi: 10.1111/ases.12197. Epub 2015 Jun 3. — View Citation

Zhang W, Zhang X, Li H, Wu F, Wang H, Zhao M, Hu H, Xu K. Prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in China: results from the China Health and Retirement Longitudinal Study. BMJ Open. 2019 Jun 19;9(6):e022792. doi: 10.1136/bmjopen-2018-022792. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AE) and serious adverse events (SAE) related to the treatment	The severity of AE is grade by Clavien-Dindo classification.	At 1 month
Secondary	Prostate volume change	Prostate volume change after treatment	Baseline, 3 months, 6 months
Secondary	Urinary symptoms measured by International Prostate Symptom Score (IPSS) score	Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom.	Baseline, 1 month, 3 months, 6 months
Secondary	Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score	Change in International Index of Erectile Function 5 questionnaire score (ranges from 0 to 25). The higher score, the more worse symptom.	Baseline, 1 month, 3 months, 6 months
Secondary	Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score	Change in MSHQ-EjD-SF questionnaire score (Range from 1-15 for function and and 0-5 for bother). The higher score, the more worse symptom.	Baseline, 1 month, 3 months, 6 months
Secondary	Change in urodynamic in uroflowmetry	Change in urodynamic function assessed by uroflowmetry, parameters include voided volume, maximum flow rate and post-void residual.	Baseline, 1 month, 3 months, 6 months
Secondary	PSA change	PSA change after treatment	Baseline, 3 months, 6 months
Secondary	Average patient post-operative pain level	Assessed by a pain numeric rating scale, Score 0-10, the higher score the worsen pain	Baseline, 2 and 4 hours after the procedure and at 1-week
Secondary	Patient quality of life	Assessed with the EQ-5D-5L questionnaire, the higher the score the better in quality of life	Baseline, 1-week, 1-month, 3-month, and 6-month,
Secondary	Patient satisfaction	Assessed with the PGI-I questionnaire,the lower score the more satisfaction	Baseline, 1-week, 1-month, 3-month, and 6-month,
Secondary	Ease of the procedure measured with a score chosen by the operator	1: easy, 2: moderate, 3: difficult	Post procedure immediately
Secondary	Ablation treatment time	Duration of the ablation procedure	Intra-operation
Secondary	Length of hospital stay	Total number of days of hospitalization for the surgical procedure	The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure]
Secondary	Operation time	Duration of patients stay in Operation Room	Intra-operation