Clinical trial NCT04198103: Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: BPH
Lower Urinary Tract Symptoms
Keywords: BPH
LUTS
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
Collaborators: name: Ospedale Regina Apostolorum
name: European Institute of Oncology
First posted: 2019-12-13
Enrollment: 160
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical symptoms changes at 6 months and 12 months follow-up evaluated with objective and subjective parameters
timeFrame: 12 months
Secondary outcomes:
measure: Treatment safety measured by complications incidence
timeFrame: 30 days
Other outcomes:
Locations:
city: Atripalda
country: Italy
facility: Casa di Cura Santa Rita
state: AV
city: Seriate
country: Italy
facility: ASST Bergamo Est
state: BG
city: Rome
country: Italy
facility: Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology
state: RM
city: Cosenza
country: Italy
facility: IGreco Ospedali Riuniti
Study officials:
References:
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.
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.
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.
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. doi: 10.1097/01.RVI.0000170858.46668.65.
citation: 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.
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. doi: 10.1111/j.1464-410x.1992.tb15631.x.