Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study - Results at 6 and 12 Months From a Retrospective Multi-centric Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04198103
• Other study ID #: RS.99
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2019
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigated the effectiveness and safety of SoracteLite ™- Trans-Perineal Laser ablation (TPLA) in the treatment of patients with symptomatic Benign Prostatic Hyperplasia (BPH) at 6 and 12 months follow-up

Description:

The purpose of this study was to investigate the effectiveness and safety of SoracteLite ™ - Trans-Perineal Laser ablation (TPLA) in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) at 6 and 12 months follow-up. Methods: Patients with urinary symptoms secondary to BPH underwent TPLA under local anaesthesia in four centers. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: March 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Male

• = 50 years of age

• International Prostate Symptoms (IPSS) =12

• Peak urinary flow rate (Qmax): <15 ml

• Prostate volume: = 30 ml, measured by transrectal ultrasound

• Post-void residual (PVR): <400 ml

• Signed informed consent

Exclusion Criteria:

• MRI signs of malignancy confirmed by biopsy investigation

• urethral stenosis

• serious coagulation disorders

• inadequate compliance

• ischemic pathology in the previous six months

• active phase inflammatory pathology

Related Conditions & MeSH terms

• BPH
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• Transperineal Focal Laser Ablation (TPLA)
The intervention will take place in an ambulatory setting using EchoLaser system. The treatment consists of the trasmission of laser energy into the tissue through the percutaneous insertion of optical fiber under local anesthesia. Within each needle, an optic fiber of 300 µm will be inserted. Each ablation lasts 6 minutes and each fiber ablates 1800J at a power of 3W. At the end of the first ablation there is a pull-back of about 1 cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used for a total duration of about 30minutes. At the end of the treatment corticosteroid is given for anti-edema and anti-inflammatory effects and Antibiotic therapy and gastroprotective therapy is given. After an adequate amount of time for observation, the patient is dismissed.

Locations

Country	Name	City	State
Italy	Casa di Cura Santa Rita	Atripalda	AV
Italy	IGreco Ospedali Riuniti	Cosenza
Italy	Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology	Rome	RM
Italy	ASST Bergamo Est	Seriate	BG

Sponsors (3)

Lead Sponsor	Collaborator
University of Rome Tor Vergata	European Institute of Oncology, Ospedale Regina Apostolorum

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Bremer C, Kreft G, Roggan A, Filler T, Reimer P. Ex vivo evaluation of novel miniaturized laser-induced interstitial thermotherapy applicators for effective small-volume tissue ablation. Invest Radiol. 2001 Jun;36(6):327-34. — View Citation

Costello AJ, Bowsher WG, Bolton DM, Braslis KG, Burt J. Laser ablation of the prostate in patients with benign prostatic hypertrophy. Br J Urol. 1992 Jun;69(6):603-8. — View Citation

Goldberg SN, Grassi CJ, Cardella JF, Charboneau JW, Dodd GD 3rd, Dupuy DE, Gervais D, Gillams AR, Kane RA, Lee FT Jr, Livraghi T, McGahan J, Phillips DA, Rhim H, Silverman SG; Society of Interventional Radiology Technology Assessment Committee. Image-guided tumor ablation: standardization of terminology and reporting criteria. J Vasc Interv Radiol. 2005 Jun;16(6):765-78. — View Citation

Lindner U, Weersink RA, Haider MA, Gertner MR, Davidson SR, Atri M, Wilson BC, Fenster A, Trachtenberg J. Image guided photothermal focal therapy for localized prostate cancer: phase I trial. J Urol. 2009 Oct;182(4):1371-7. doi: 10.1016/j.juro.2009.06.035. Epub 2009 Aug 14. — View Citation

Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4. — View Citation

Raz O, Haider MA, Davidson SR, Lindner U, Hlasny E, Weersink R, Gertner MR, Kucharczyk W, McCluskey SA, Trachtenberg J. Real-time magnetic resonance imaging-guided focal laser therapy in patients with low-risk prostate cancer. Eur Urol. 2010 Jul;58(1):173-7. doi: 10.1016/j.eururo.2010.03.006. Epub 2010 Mar 12. Erratum in: Eur Urol. 2010 Sep;58(3):473. Kucharcyzk, Walter [corrected to Kucharczyk, Walter]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical symptoms changes at 6 months and 12 months follow-up evaluated with objective and subjective parameters	Improvement of obstructive symptomatology correlated to BPH. The evaluation will be based on urodynamic studies of Qmax, post void and residual volume	12 months
Secondary	Treatment safety measured by complications incidence	Number of incidence of Complication according to modified Clavien classification system	30 days