Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia
Primary Purpose
BPH, Lower Urinary Tract Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Transperineal Focal Laser Ablation (TPLA)
Sponsored by
About this trial
This is an interventional treatment trial for BPH focused on measuring BPH, LUTS
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
Sites / Locations
- Casa di Cura Santa Rita
- ASST Bergamo Est
- Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology
- IGreco Ospedali Riuniti
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SoracteLite
Arm Description
Transperineal Focal Laser Ablation (TPLA)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Treatment safety measured by complications incidence
Number of incidence of Complication according to modified Clavien classification system
Full Information
NCT ID
NCT04198103
First Posted
November 8, 2019
Last Updated
December 12, 2019
Sponsor
University of Rome Tor Vergata
Collaborators
Ospedale Regina Apostolorum, European Institute of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT04198103
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rome Tor Vergata
Collaborators
Ospedale Regina Apostolorum, European Institute of Oncology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH, Lower Urinary Tract Symptoms
Keywords
BPH, LUTS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SoracteLite
Arm Type
Experimental
Arm Description
Transperineal Focal Laser Ablation (TPLA)
Intervention Type
Device
Intervention Name(s)
Transperineal Focal Laser Ablation (TPLA)
Other Intervention Name(s)
SoracteLite EchoLaser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical symptoms changes at 6 months and 12 months follow-up evaluated with objective and subjective parameters
Description
Improvement of obstructive symptomatology correlated to BPH. The evaluation will be based on urodynamic studies of Qmax, post void and residual volume
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Treatment safety measured by complications incidence
Description
Number of incidence of Complication according to modified Clavien classification system
Time Frame
30 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Casa di Cura Santa Rita
City
Atripalda
State/Province
AV
ZIP/Postal Code
83042
Country
Italy
Facility Name
ASST Bergamo Est
City
Seriate
State/Province
BG
ZIP/Postal Code
24068
Country
Italy
Facility Name
Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology
City
Rome
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Facility Name
IGreco Ospedali Riuniti
City
Cosenza
ZIP/Postal Code
87100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28474112
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.
Results Reference
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PubMed Identifier
20334965
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].
Results Reference
background
PubMed Identifier
19683262
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.
Results Reference
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PubMed Identifier
15947040
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.
Results Reference
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PubMed Identifier
11410753
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.
Results Reference
background
PubMed Identifier
1379101
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.
Results Reference
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Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia
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