Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia

NCT04198103 | Unknown DMC

• 1 other identifier: RS.99
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

BPH; Lower Urinary Tract Symptoms

Keywords

BPH; LUTS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Treatment safety measured by complications incidence

  30 days

Study Arms (1)

SoracteLite

EXPERIMENTAL

Transperineal Focal Laser Ablation (TPLA)

Device: Transperineal Focal Laser Ablation (TPLA)

Interventions

Transperineal Focal Laser Ablation (TPLA) DEVICE

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.

Also known as: SoracteLite EchoLaser

SoracteLite

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead
• Ospedale Regina Apostolorum: collaborator
• European Institute of Oncology: collaborator

Study Sites (4)

Casa di Cura Santa Rita

Atripalda, AV, 83042, Italy

Location

ASST Bergamo Est

Seriate, BG, 24068, Italy

Location

Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology

Rome, RM, 00133, Italy

Location

IGreco Ospedali Riuniti

Cosenza, 87100, Italy

Location

Related Publications (6)

• 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.

  PMID: 28474112 BACKGROUND

• 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.

  PMID: 20334965 BACKGROUND

• 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.

  PMID: 19683262 BACKGROUND

• 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. doi: 10.1097/01.RVI.0000170858.46668.65.

  PMID: 15947040 BACKGROUND

• 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. doi: 10.1097/00004424-200106000-00005.

  PMID: 11410753 BACKGROUND

• 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. doi: 10.1111/j.1464-410x.1992.tb15631.x.

  PMID: 1379101 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: December 13, 2019
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: March 1, 2020
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)