Benign Prostatic HyperplasiaNCT04044573
Focal Laser Ablation for Benign Prostatic Hyperplasia
A study testing Transperineal Focal Laser Ablation (TPLA) in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study Read more about this study
- Who is it for?
- Ages 51 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Transperineal Focal Laser Ablation (TPLA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2018to 5 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 50 years old
- BPH confirmed by mpMRI
- Uroflowmetry indicating obstructive pathology
- Surgical risk moderate-elevated
- Symptomatology of obstructive pathology (voiding hesitation, intermittent mitt, urinary flow reduction, incomplete emptying of the bladder, post-urination incontinence and irritative symptoms such as urinary frequency, dysuria, nocturia - quantified with IPSS)
- Signature of the information sheet and of the informed consent to the treatment, at the execution of the multiparametric MRI and the administration of the paramagnetic contrast medium.
Who cannot join
- MRI signs of malignancy confirmed by biopsy investigation
- Urethral stenosis
- Serious coagulation disorders
- Inadequate compliance
- Ischemic pathology in the previous six months
- Presence of pacemakers
Show all 12Show fewer
- Active phase inflammatory pathology
- Presence of III dominant prostate lobe
- Contraindications to the execution of MRI (claustrophobia, auricular implants, metal prostheses and other contraindications included in the specific informed consent)
- Paramagnetic contrast medium allergy.
- Acute and / or chronic renal failure (GFR <50 mL / min and serum creatinine> 1.5 mg / d)
- Not adequate understanding of the information sheet
Trial locations and contacts
1 site in 1 country.
Salvatore Marsico, MD PhD contact
Italy1 site, 1 recruiting
- Recruiting
Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology
Rome, RM, 00133
Guglielmo Manenti, MD PhD, +39 0620902281, gu.manenti@gmail.com
Roberto Floris, FACS, +39 0620902400, roberto.floris@uniroma2.it
About this study
Official title: Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
Read the detailed description
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
The aim of this pilot study is to evaluate the efficacy of TPLA under US-guidance and the safety and the reproducibility in acute and follow-up.
Objective of the study: Evaluate the efficacy of percutaneous ablative treatment with neodymium laser; the complete profile of safety and tolerability in acute and in the follow-up in patients with Benign Prostatic Hypertrophy by using multiparametric prostate MRI that allows us to evaluate the prostate acutely after treatment and in follow-up. All of the imaging data is correlated with clinical and laboratory data.
Design of the study: Non-pharmacological interventional study. The clinical evaluation will be carried out at three different times:
Time 1: eligibility assessment, signing of informed consent Time 2: admission, laser ablation and control with multiparametric MRI of the post-procedural prostate (T0).
Time 3 Follow up at 3 (T1) -6 (T2) -12 (T3) months from the procedure.
There are various inclusion and exclusion criteria. The inclusion criteria are: over 65 years old, benign prostate hypertrophy (BPH) confirmed by pre-interventional multi-parametric (mpMRI), moderate-elevated surgical risk, presence of urinary obstructive symptoms, signed consent form. Exclusion criteria are: presence of prostate tumor diagnosed by MRI and confirmed by biopsy, urethral stenosis, severe coagulation pathology, ischemic pathology, pacemaker presence, inflammatory pathology in acute phase, presence of 3rd dominant lobe and contraindication to MRI.
Pre-treatment blood chemistry tests:
- Total and fractionated PSA
- Complete blood count with platelet count and leukocyte formula
- Blood coagulation tests
- Urine test - urine culture
- Azotemia
- Creatinine
Technique of performing a percutaneous laser ablation treatment:
The treatments are performed by the radiology team, in an outpatient setting using the Echolaser XVG combined system.
The procedure is performed with the patient in gynecological position, and in safe conditions according to the current legislation for laser treatments (such as protective glasses).
Treatment includes local anesthesia of the perineal region, under ultrasound guidance. At the discretion of the medical team, sedation can be carried out with anesthetic assistance.
2 or 4 needles of 21G, 1 or 2 will be inserted. In each needle a 300 micron optical fiber will be inserted - Elesta s.r.l. - 50041, Calenzano (FI) - Italy, at a distance of 8-10 mm from the urethra. For each ablation, for about 6 minutes, an energy of 1200 J per fiber will be delivered, at the power of 2-5 Watts. At the end the needle and the fiber is retracted for about 1 cm ("pull-back"). Further ablation follows, with delivery and duration and power equal to the previous one. Depending on the size of the middle lobe one or more pull-backs can be made. In total the treatment consists in dispensing up to 1800 J, at the power of 2-5 W for a total duration of 30 minutes.
The laser causes hyperthermia, denaturation and coagulative necrosis of proteins.
The maximum volume treated in a session and the extent of the ablation vary according to the prostatic volume, anatomy and receptivity of the tissue.
At the end of the treatment 20 mg of corticosteroids ev (if not specifically contraindicated by the patient) is administered, for anti-edema and anti-inflammatory purposes. An antibiotic, pain relief and gastroprotective therapy is established for 1 week. After an adequate observation period, the patient will be discharged.
Follow up: The clinical evaluation is carried out at different times
Post procedural follow up:
Immediately after the procedure, a multiparametric prostate MRI is performed, followed by discharge with steroid therapy (prednisone), if not contraindicated, to be scaled and for programming the subsequent follow-up phases.
Post-discharge follow-up:
Specialist examination, suprapubic ultrasound of the urinary tract (with evaluation of the post-residual volume) and multiparametric prostate MRI at 3 months, 6 months and 12 months and subsequent checks according to clinical judgment.
A urine test and any urine culture are attached to each clinical-ultrasound evaluation. At each revaluation the IPSS form and the data collection form is filled out.
- Being tested
- Transperineal Focal Laser Ablation (TPLA)
- Keywords
- BPH, mpMRI, interventional radiology
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal Focal Laser Ablation (TPLA)Procedure or surgery
Also called Focal Laser Ablation
The intervention will take place in an ambulatory setting of the interventional radiology department using the combined Echolaser XVG system. The treatment consists of a local anesthesia to the perineal region. Within each needle, an optic fiber of 300um will be inserted. Each ablation lasts 6 minutes and each fiber ablates1800J at a power of 2-3W. At the end of the ablation there is a pull-back of about 1cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used. The total ablation is 3600J for 2 fibers (1800J/ fiber) at the power of 2-3W for a total duration of about 30minutes. At the end of the treatment, a 20mg bolus of i.v. corticosteroid is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Ciprofloxacin 500mg and gastroprotective therapy is given for 5 days. After an adequate amount of time for observation, the patient is dismissed.
| Study group | Role | What they receive |
|---|---|---|
| ECHOLASER X4 Socratelite | Experimental | Optic fiber of 300um will be inserted at a distance of 8-10mm from the urethra. Each ablation lasts 6 minutes. Each fiber ablates at an energy of 1800J with a power of 2-3W. Treatment lasts for about 30 minutes. Receives: Procedure: Transperineal Focal Laser Ablation (TPLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptoms at 1-yr follow-up evaluated with usual 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.
Measured: 12 months
Rate of complication needing re-hospitalisation or reintervention
Evaluation of complications post TPLA treatment by MRI.
Measured: procedure date to 12 months
Secondary outcomes (4)
Reproducibility of Multi-parametric MRI
Evaluation of multi-parametric MRI of the prostate to quantify and/or preview coagulative necrosis after treatment and evaluate the response to transperineal laser ablation treatment for lower urinary tract symptoms.
Measured: 12 months.
Total and post-operative costs during follow-up compared to transurethral resection of the prostate
Calculation and stratification of prodecural costs in in comparison to transurethral resection of the prostate (TURP).
Measured: 12 months
Evaluation of Quality of Life by International Prostate Symptom Score
Evaluation of quality of life quantified by the questionnaire (IPSS)
Measured: 12 months
Evaluation of Quality of Life by International Index of Erectile Function
Evaluation of Quality of Life by International Index of Erectile Function (IIEF)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start5 May 2018
- Primary completion5 Apr 2023 (estimated)
- Study completion5 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guglielmo Manenti, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044573
- Sponsor's protocol ID
- R.S.71.18
- Status last verified
- Aug 2019
- First submitted
- 11 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Create an international registry to assess long-term effectiveness of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations. It an international prospective observational registry in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms.
Publications
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.
PubMed 28474112Raz 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.
PubMed 20334965Lindner 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.
PubMed 19683262Goldberg 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.
PubMed 15947040Bremer 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.
PubMed 11410753Costello 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.
PubMed 1379101Manenti G, Perretta T, Calcagni A, Ferrari D, Ryan CP, Fraioli F, Meucci R, Malizia A, Iacovelli V, Agro EF, Floris R. 3-T MRI and clinical validation of ultrasound-guided transperineal laser ablation of benign prostatic hyperplasia. Eur Radiol Exp. 2021 Sep 17;5(1):41. doi: 10.1186/s41747-021-00239-9.
PubMed 34532768
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
- ClinicalTrials.gov ID
- NCT04044573
- Acronym / sponsor ID
- R.S.71.18
- Keywords
- BPH, mpMRI, interventional radiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- 5 Apr 2023 (estimated)
- Study completion
- 5 Apr 2023 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
Detailed description
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
The aim of this pilot study is to evaluate the efficacy of TPLA under US-guidance and the safety and the reproducibility in acute and follow-up.
Objective of the study: Evaluate the efficacy of percutaneous ablative treatment with neodymium laser; the complete profile of safety and tolerability in acute and in the follow-up in patients with Benign Prostatic Hypertrophy by using multiparametric prostate MRI that allows us to evaluate the prostate acutely after treatment and in follow-up. All of the imaging data is correlated with clinical and laboratory data.
Design of the study: Non-pharmacological interventional study. The clinical evaluation will be carried out at three different times:
Time 1: eligibility assessment, signing of informed consent Time 2: admission, laser ablation and control with multiparametric MRI of the post-procedural prostate (T0).
Time 3 Follow up at 3 (T1) -6 (T2) -12 (T3) months from the procedure.
There are various inclusion and exclusion criteria. The inclusion criteria are: over 65 years old, benign prostate hypertrophy (BPH) confirmed by pre-interventional multi-parametric (mpMRI), moderate-elevated surgical risk, presence of urinary obstructive symptoms, signed consent form. Exclusion criteria are: presence of prostate tumor diagnosed by MRI and confirmed by biopsy, urethral stenosis, severe coagulation pathology, ischemic pathology, pacemaker presence, inflammatory pathology in acute phase, presence of 3rd dominant lobe and contraindication to MRI.
Pre-treatment blood chemistry tests:
- Total and fractionated PSA
- Complete blood count with platelet count and leukocyte formula
- Blood coagulation tests
- Urine test - urine culture
- Azotemia
- Creatinine
Technique of performing a percutaneous laser ablation treatment:
The treatments are performed by the radiology team, in an outpatient setting using the Echolaser XVG combined system.
The procedure is performed with the patient in gynecological position, and in safe conditions according to the current legislation for laser treatments (such as protective glasses).
Treatment includes local anesthesia of the perineal region, under ultrasound guidance. At the discretion of the medical team, sedation can be carried out with anesthetic assistance.
2 or 4 needles of 21G, 1 or 2 will be inserted. In each needle a 300 micron optical fiber will be inserted - Elesta s.r.l. - 50041, Calenzano (FI) - Italy, at a distance of 8-10 mm from the urethra. For each ablation, for about 6 minutes, an energy of 1200 J per fiber will be delivered, at the power of 2-5 Watts. At the end the needle and the fiber is retracted for about 1 cm ("pull-back"). Further ablation follows, with delivery and duration and power equal to the previous one. Depending on the size of the middle lobe one or more pull-backs can be made. In total the treatment consists in dispensing up to 1800 J, at the power of 2-5 W for a total duration of 30 minutes.
The laser causes hyperthermia, denaturation and coagulative necrosis of proteins.
The maximum volume treated in a session and the extent of the ablation vary according to the prostatic volume, anatomy and receptivity of the tissue.
At the end of the treatment 20 mg of corticosteroids ev (if not specifically contraindicated by the patient) is administered, for anti-edema and anti-inflammatory purposes. An antibiotic, pain relief and gastroprotective therapy is established for 1 week. After an adequate observation period, the patient will be discharged.
Follow up: The clinical evaluation is carried out at different times
Post procedural follow up:
Immediately after the procedure, a multiparametric prostate MRI is performed, followed by discharge with steroid therapy (prednisone), if not contraindicated, to be scaled and for programming the subsequent follow-up phases.
Post-discharge follow-up:
Specialist examination, suprapubic ultrasound of the urinary tract (with evaluation of the post-residual volume) and multiparametric prostate MRI at 3 months, 6 months and 12 months and subsequent checks according to clinical judgment.
A urine test and any urine culture are attached to each clinical-ultrasound evaluation. At each revaluation the IPSS form and the data collection form is filled out.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECHOLASER X4 Socratelite | Experimental | Procedure: Transperineal Focal Laser Ablation (TPLA)Optic fiber of 300um will be inserted at a distance of 8-10mm from the urethra. Each ablation lasts 6 minutes. Each fiber ablates at an energy of 1800J with a power of 2-3W. Treatment lasts for about 30 minutes. |
Who may qualify
- Ages
- 51 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 50 years old
- BPH confirmed by mpMRI
- Uroflowmetry indicating obstructive pathology
- Surgical risk moderate-elevated
- Symptomatology of obstructive pathology (voiding hesitation, intermittent mitt, urinary flow reduction, incomplete emptying of the bladder, post-urination incontinence and irritative symptoms such as urinary frequency, dysuria, nocturia - quantified with IPSS)
Key exclusion criteria (12 listed)
- MRI signs of malignancy confirmed by biopsy investigation
- Urethral stenosis
- Serious coagulation disorders
- Inadequate compliance
- Ischemic pathology in the previous six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transperineal Focal Laser Ablation (TPLA)Also: Focal Laser AblationThe intervention will take place in an ambulatory setting of the interventional radiology department using the combined Echolaser XVG system. The treatment consists of a local anesthesia to the perineal region. Within each needle, an optic fiber of 300um will be inserted. Each ablation lasts 6 minutes and each fiber ablates1800J at a power of 2-3W. At the end of the ablation there is a pull-back of about 1cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used. The total ablation is 3600J for 2 fibers (1800J/ fiber) at the power of 2-3W for a total duration of about 30minutes. At the end of the treatment, a 20mg bolus of i.v. corticosteroid is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Ciprofloxacin 500mg and gastroprotective therapy is given for 5 days. After an adequate amount of time for observation, the patient is dismissed. | Procedure or surgery | ECHOLASER X4 Socratelite |
Primary outcome
Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters
Time frame: 12 months
Improvement of obstructive symptomatology correlated to BPH. The evaluation will be based on urodynamic studies of Qmax, post void and residual volume.
Rate of complication needing re-hospitalisation or reintervention
Time frame: procedure date to 12 months
Evaluation of complications post TPLA treatment by MRI.
4 secondary outcomes
Reproducibility of Multi-parametric MRI
Time frame: 12 months.
Total and post-operative costs during follow-up compared to transurethral resection of the prostate
Time frame: 12 months
Evaluation of Quality of Life by International Prostate Symptom Score
Time frame: 12 months
Evaluation of Quality of Life by International Index of Erectile Function
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Background: PubMed 28474112Patelli 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.
- Background: PubMed 20334965Raz 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.
- Background: PubMed 19683262Lindner 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.
- Background: PubMed 15947040Goldberg 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.
- Background: PubMed 11410753Bremer 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.
- Background: PubMed 1379101Costello 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.
- Derived from this study: PubMed 34532768Manenti G, Perretta T, Calcagni A, Ferrari D, Ryan CP, Fraioli F, Meucci R, Malizia A, Iacovelli V, Agro EF, Floris R. 3-T MRI and clinical validation of ultrasound-guided transperineal laser ablation of benign prostatic hyperplasia. Eur Radiol Exp. 2021 Sep 17;5(1):41. doi: 10.1186/s41747-021-00239-9.
- Individual participant dataSharing planned: Yes. Create an international registry to assess long-term effectiveness of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations. It an international prospective observational registry in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Marsico, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal Focal Laser Ablation (TPLA) in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by University of Rome Tor Vergata at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guglielmo Manenti, MD PhD (+39 0620902400 ext. 2401, gu.manenti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04044573, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.