Prostate CancerNCT04045756
Focal Laser Ablation for the Treatment of Focal Low-Intermediate Risk Prostate Cancer
A study testing Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA) in people with Prostate Cancer, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Short-term Efficacy of Transperineal Laser Ablation (TPLA) with Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study. Read more about this study
- Who is it for?
- Ages 46 to 86 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 2 Aug 2019to 2 Aug 2024
- 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 46 to 86 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Over 45 years old
- Prostate cancer identified after prostatic biopsy with fusion of images with target and systematic samples (> 12)
- Intermediate progression risk (Gleason Score 3 + 4 or 4 + 3; PSA <15 ng / ml; clinical stage T1-T2a)
- Low risk of progression (Gleason score 3 + 3) only in patients who wish to leave or who refuse the active surveillance protocol and who refuse validated treatments for the treatment of organo-confined prostate cancer: radical surgery and / or radiotherapy
Who cannot join
- Prostate cancer Gleason Score> = 4 + 4.
- Clinical stage> T2a
- PSA> 15 ng / ml
- Presence of metastases from prostate lymph node, bone or visceral carcinoma detected by bone scintigraphy, total body CT or PET-CT
- Serious coagulation disorders not correctable
- Unavailable or replaceable anticoagulant and / or antiplatelet therapy
Show all 12Show fewer
- Inadequate compliance
- Presence of pacemakers
- Contraindications to MRI (claustrophobia, ear implants, metal prostheses)
- Paramagnetic contrast agent allergy
- Acute and / or chronic renal failure (GFR <50 mL / min and serum creatinine> 1.5 mg / dl)
- Tumor volume <15 ml measured on MRI
Trial locations and contacts
1 site in 1 country.
Salvatore Marsico, MD PhD contact
Italy1 site, 1 recruiting
- Recruiting
Policlinico Tor Vergata (PTV) Foundation: Department di Biomedicine and Prevention
Rome, RM, 00133
Guglielmo Manenti, MD PhD, +39 0620902281, gu.manenti@gmail.com
Roberto Floris, MD PhD, +39 0620902400, roberto.floris@uniroma2.it
About this study
Official title: Short-term Efficacy of Transperineal Laser Ablation (TPLA) With Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer: Interventional Pilot Study
Short-term Efficacy of Transperineal Laser Ablation (TPLA) with Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study. The clinical evaluation will be carried out at different times as follows:
Time 0: recruitment and eligibility assessment (patient selection) Time 1: interview, signing of informed consent and enrollment Time 2: FLA treatment and control with multiparametric MRI of the post-procedural prostate.
Read more
Time 3-4-5-6: follow up to 1 (T3), 6 (T4), 12 (T5) and 24 (T6) months from the procedure.
The primary objective of the study is to evaluate the short-term (2 years) efficacy of FLA treatment of low-intermediate risk prostate cancer Secondary objective is to investigate multiparametric prostate MRI as a follow-up diagnostic investigation, evaluating possible glandular morphostructural changes and their correlation with clinical data.
Read the detailed description
Short-term Efficacy of Transperineal Laser Ablation (TPLA) With Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study.
The recruitment and evaluation of eligibility will be done by the Multidisciplinary Neoplasms Group of the Uro-Genital System, already operating within the Tor Vergata Polyclinic Foundation and formed by the following Operating Units:
UOSD Urology, UOC Diagnostic Imaging, UOC Medical Oncology, UOC Radiotherapy, UOSD Pathological Anatomy, UOC Nuclear Medicine. The Multidisciplinary Group will propose and evaluate patients that can be recruited based on inclusion and exclusion criteria. The patient considered eligible for the study will be adequately informed by the UOSD Urology / UOC Diagnostic Imaging regarding the therapeutic possibilities for the specific disease stage.
If the patient expresses an interest in participating in the study, he will be given informed consent.
Once the informed consent has been signed, the patient will be considered enrolled in the study.
Pre-procedural evaluation
Pre-treatment clinical-instrumental-blood chemistry tests include:
- Electrocardiogram
- Complete blood count, blood ureanitrogen (BUN), creatinine, sodium, potassium, coagulation tests
- Urine examination and urine culture
- Evaluation of the post-voiding residue
- Uroflowmetry (if IPSS> 7)
Questionnaires:
- IPSS-QoL
- IIEF
Focal laser ablation treatment (FLA):
The treatments will be performed by the Diagnostic Imaging team, on a Day Hospital basis, using the combined Echolaser XVG system (Elesta s.r.l - Calenzano (FI)).
The EchoLaser Therapy is a micro-invasive percutaneous procedure that uses the laser light transmitted through applicators (optical fibers) for a few minutes, causing the affected tissue to warm up until it is irreversibly damaged in "situ", without the need to remove it.
All this thanks to the combined action of an increase in the local temperature and the exposure time. The interaction of laser radiation with a wavelength of 1064nm (in the range of the therapeutic window) is excellent, with low radiation absorption and excellent light penetration. The laser light is conveyed from the source to the fabric through extremely flexible, small-caliber (300 micron diameter) flat-tip quartz optical fibers, introduced percutaneously by thin needles (21 Gauge).
The EchoLaser Therapy, through flat-tipped fibers, produces an ellipsoidal coagulation area (an area where the tissue has irreversible damage). A possible multi-fiber approach can extend the coagulation area.
The EchoLaser Therapy can be performed under ultrasound guidance for real-time monitoring of the correct positioning of the laser light applicators and the effective extension of the damage to the tumor lesion.
The procedure will be performed with a patient in a lithotomy position and in safe conditions according to the current legislation for treatments with laser systems (such as protective glasses).
Treatment includes local anesthesia of the perineal region, under ultrasound guidance. At the discretion of the medical team, intravenous sedation can be performed.
1-2 spinal needles 21G will be inserted into the intralesional site by ultrasound-guided transperineal route after MRI / TRUS image fusion. In each needle a 300 micron optical fiber will be inserted (Elesta s.r.l., Calenzano (FI)). For each lighting, for about 6 minutes, a maximum energy of 1800 J per fiber will be delivered, with a power of 2-5 Watts. If necessary, the needle and fiber will be retracted for about 1 cm ("pull-back"). Further lighting will follow, with delivery and duration and power equal to the previous one.
Immediately after the procedure, the patient will be asked to complete the VAS score for the assessment of pain felt during the procedure.
Complications: The potential complications of the FLA technique are:
- Peri-operative: perineal and hypogastric pain, perineal hematoma, hematuria, acute urinary retention, fever, dysuria
- Postoperative: perineal pain, LUTS, persistent hematuria, hematospermia, erectile dysfunction, urinary incontinence Complications will be investigated prospectively using the Clavien-Dindo classification
Follow-up: The clinical evaluation will be carried out at different times:
Post procedural follow up A multi-parametric prostate MRI will be performed immediately after the treatment. At the end of the treatment the resumption of spontaneous diuresis will be checked and in the case of acute urinary retention / clinically significant hematuria a bladder catheter will be inserted.
An oral cortisone drug (Deflazacort 30 mg) or other anti-edema therapy will be prescribed if specifically contraindicated by the patient.
Any complications will be recorded according to the Clavien-Dindo classification The patient will be discharged with antibiotic therapy, pain relief when needed and gastroprotective for 5-7 days.
Patients will receive a telephone contact to use to communicate any post-operative emergencies.
Post-discharge follow-up The specialist follow-up visit to 1 (T3), 6 (T4), 12 (T5) and 24 (T6) months from the procedure will be conducted by the UOSD Urology.
Any reported complications will be recorded according to the Clavien-Dindo classification.
The patient will be asked to complete the IPSS-QoL and IIEF questionnaires and will view the total serum PSA (T4-T5-T6).
Multi-parametric prostate MRI will be performed at T4-T6. Transperineal prostatic control biopsy will be performed with fusion target (ablated zone) and systematic technique (T4-T6).
- Conditions
- Prostate Cancer
- Being tested
- Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA)
- Keywords
- prostate cancer, laser ablation, mpMRI, interventional radiology
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA)Device
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 ablates 1800J 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 bollous of i.v. corticosteriods () is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Cirpofloxacin 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: Device: Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results in a 5 year period.
Measured: 5 years
Evaluation of Complications of prostate Laser Ablation on the Treatment of Focal Low-Intermediate Risk Prostate Cancer by use of mp-MRI.
Evaluation of the post-procedural complications by mpMRI. In particular damage to neuro-vascular bundles, seminal vescicles and peri-prostatic fat will be checked.
Measured: 5 years
Secondary outcomes (1)
Reproducibility of mpMRI in correlation with biopsy in order to establish positive/negative predictive diagnostic values of MRI in residual/relapsing tumors
Evaluation of multi-parametric MRI of the prostate and evaluate the response to focal laser ablation treatment for focal low-intermediate prostate cancer by biopsy.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start2 Aug 2019
- Primary completion2 Aug 2020 (estimated)
- Study completion2 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- 50 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
- Investigators
- Guglielmo Manenti, MD PhD, Principal investigator, Fondazione Policlinico Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045756
- Sponsor's protocol ID
- R.S. 68.19
- Status last verified
- Dec 2019
- First submitted
- 11 Jul 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 focal prostate cancer, 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 low-intermediate risk focal prostate cancer.
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 28474112Lindner U, Lawrentschuk N, Trachtenberg J. Image guidance for focal therapy of prostate cancer. World J Urol. 2010 Dec;28(6):727-34. doi: 10.1007/s00345-010-0604-9. Epub 2010 Oct 21.
PubMed 20963422Lindner 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, Johnson DE, Bolton DM. Nd:YAG laser ablation of the prostate as a treatment for benign prostatic hypertrophy. Lasers Surg Med. 1992;12(2):121-4. doi: 10.1002/lsm.1900120202.
PubMed 1374142Oto A, Sethi I, Karczmar G, McNichols R, Ivancevic MK, Stadler WM, Watson S, Eggener S. MR imaging-guided focal laser ablation for prostate cancer: phase I trial. Radiology. 2013 Jun;267(3):932-40. doi: 10.1148/radiol.13121652. Epub 2013 Feb 25.
PubMed 23440319van Luijtelaar A, Greenwood BM, Ahmed HU, Barqawi AB, Barret E, Bomers JGR, Brausi MA, Choyke PL, Cooperberg MR, Eggener S, Feller JF, Frauscher F, George AK, Hindley RG, Jenniskens SFM, Klotz L, Kovacs G, Lindner U, Loeb S, Margolis DJ, Marks LS, May S, Mcclure TD, Montironi R, Nour SG, Oto A, Polascik TJ, Rastinehad AR, De Reyke TM, Reijnen JS, de la Rosette JJMCH, Sedelaar JPM, Sperling DS, Walser EM, Ward JF, Villers A, Ghai S, Futterer JJ. Focal laser ablation as clinical treatment of prostate cancer: report from a Delphi consensus project. World J Urol. 2019 Oct;37(10):2147-2153. doi: 10.1007/s00345-019-02636-7. Epub 2019 Jan 22.
PubMed 30671638Walser E, Nance A, Ynalvez L, Yong S, Aoughsten JS, Eyzaguirre EJ, Williams SB. Focal Laser Ablation of Prostate Cancer: Results in 120 Patients with Low- to Intermediate-Risk Disease. J Vasc Interv Radiol. 2019 Mar;30(3):401-409.e2. doi: 10.1016/j.jvir.2018.09.016.
PubMed 30819483Lepor H. Vascular targeted photodynamic therapy for localized prostate cancer. Rev Urol. 2008 Fall;10(4):254-61.
PubMed 19145269Manenti G, Perretta T, Nezzo M, Fraioli FR, Carreri B, Gigliotti PE, Micillo A, Malizia A, Di Giovanni D, Ryan CP, Garaci FG. Transperineal Laser Ablation (TPLA) Treatment of Focal Low-Intermediate Risk Prostate Cancer. Cancers (Basel). 2024 Apr 3;16(7):1404. doi: 10.3390/cancers16071404.
PubMed 38611082
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Efficacy of Transperineal Laser Ablation (TPLA) With Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer: Interventional Pilot Study
- ClinicalTrials.gov ID
- NCT04045756
- Acronym / sponsor ID
- R.S. 68.19
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, laser ablation, mpMRI, interventional radiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 2 Aug 2020 (estimated)
- Study completion
- 2 Aug 2024 (estimated)
- First posted
- 6 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.
Short-term Efficacy of Transperineal Laser Ablation (TPLA) with Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study. The clinical evaluation will be carried out at different times as follows:
Time 0: recruitment and eligibility assessment (patient selection) Time 1: interview, signing of informed consent and enrollment Time 2: FLA treatment and control with multiparametric MRI of the post-procedural prostate.
Time 3-4-5-6: follow up to 1 (T3), 6 (T4), 12 (T5) and 24 (T6) months from the procedure.
The primary objective of the study is to evaluate the short-term (2 years) efficacy of FLA treatment of low-intermediate risk prostate cancer Secondary objective is to investigate multiparametric prostate MRI as a follow-up diagnostic investigation, evaluating possible glandular morphostructural changes and their correlation with clinical data.
Detailed description
Short-term Efficacy of Transperineal Laser Ablation (TPLA) With Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study.
The recruitment and evaluation of eligibility will be done by the Multidisciplinary Neoplasms Group of the Uro-Genital System, already operating within the Tor Vergata Polyclinic Foundation and formed by the following Operating Units:
UOSD Urology, UOC Diagnostic Imaging, UOC Medical Oncology, UOC Radiotherapy, UOSD Pathological Anatomy, UOC Nuclear Medicine. The Multidisciplinary Group will propose and evaluate patients that can be recruited based on inclusion and exclusion criteria. The patient considered eligible for the study will be adequately informed by the UOSD Urology / UOC Diagnostic Imaging regarding the therapeutic possibilities for the specific disease stage.
If the patient expresses an interest in participating in the study, he will be given informed consent.
Once the informed consent has been signed, the patient will be considered enrolled in the study.
Pre-procedural evaluation
Pre-treatment clinical-instrumental-blood chemistry tests include:
- Electrocardiogram
- Complete blood count, blood ureanitrogen (BUN), creatinine, sodium, potassium, coagulation tests
- Urine examination and urine culture
- Evaluation of the post-voiding residue
- Uroflowmetry (if IPSS> 7)
Questionnaires:
- IPSS-QoL
- IIEF
Focal laser ablation treatment (FLA):
The treatments will be performed by the Diagnostic Imaging team, on a Day Hospital basis, using the combined Echolaser XVG system (Elesta s.r.l - Calenzano (FI)).
The EchoLaser Therapy is a micro-invasive percutaneous procedure that uses the laser light transmitted through applicators (optical fibers) for a few minutes, causing the affected tissue to warm up until it is irreversibly damaged in "situ", without the need to remove it.
All this thanks to the combined action of an increase in the local temperature and the exposure time. The interaction of laser radiation with a wavelength of 1064nm (in the range of the therapeutic window) is excellent, with low radiation absorption and excellent light penetration. The laser light is conveyed from the source to the fabric through extremely flexible, small-caliber (300 micron diameter) flat-tip quartz optical fibers, introduced percutaneously by thin needles (21 Gauge).
The EchoLaser Therapy, through flat-tipped fibers, produces an ellipsoidal coagulation area (an area where the tissue has irreversible damage). A possible multi-fiber approach can extend the coagulation area.
The EchoLaser Therapy can be performed under ultrasound guidance for real-time monitoring of the correct positioning of the laser light applicators and the effective extension of the damage to the tumor lesion.
The procedure will be performed with a patient in a lithotomy position and in safe conditions according to the current legislation for treatments with laser systems (such as protective glasses).
Treatment includes local anesthesia of the perineal region, under ultrasound guidance. At the discretion of the medical team, intravenous sedation can be performed.
1-2 spinal needles 21G will be inserted into the intralesional site by ultrasound-guided transperineal route after MRI / TRUS image fusion. In each needle a 300 micron optical fiber will be inserted (Elesta s.r.l., Calenzano (FI)). For each lighting, for about 6 minutes, a maximum energy of 1800 J per fiber will be delivered, with a power of 2-5 Watts. If necessary, the needle and fiber will be retracted for about 1 cm ("pull-back"). Further lighting will follow, with delivery and duration and power equal to the previous one.
Immediately after the procedure, the patient will be asked to complete the VAS score for the assessment of pain felt during the procedure.
Complications: The potential complications of the FLA technique are:
- Peri-operative: perineal and hypogastric pain, perineal hematoma, hematuria, acute urinary retention, fever, dysuria
- Postoperative: perineal pain, LUTS, persistent hematuria, hematospermia, erectile dysfunction, urinary incontinence Complications will be investigated prospectively using the Clavien-Dindo classification
Follow-up: The clinical evaluation will be carried out at different times:
Post procedural follow up A multi-parametric prostate MRI will be performed immediately after the treatment. At the end of the treatment the resumption of spontaneous diuresis will be checked and in the case of acute urinary retention / clinically significant hematuria a bladder catheter will be inserted.
An oral cortisone drug (Deflazacort 30 mg) or other anti-edema therapy will be prescribed if specifically contraindicated by the patient.
Any complications will be recorded according to the Clavien-Dindo classification The patient will be discharged with antibiotic therapy, pain relief when needed and gastroprotective for 5-7 days.
Patients will receive a telephone contact to use to communicate any post-operative emergencies.
Post-discharge follow-up The specialist follow-up visit to 1 (T3), 6 (T4), 12 (T5) and 24 (T6) months from the procedure will be conducted by the UOSD Urology.
Any reported complications will be recorded according to the Clavien-Dindo classification.
The patient will be asked to complete the IPSS-QoL and IIEF questionnaires and will view the total serum PSA (T4-T5-T6).
Multi-parametric prostate MRI will be performed at T4-T6. Transperineal prostatic control biopsy will be performed with fusion target (ablated zone) and systematic technique (T4-T6).
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 | Device: Procedure/Surgery: 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
- 46 to 86 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Over 45 years old
- Prostate cancer identified after prostatic biopsy with fusion of images with target and systematic samples (> 12)
- Intermediate progression risk (Gleason Score 3 + 4 or 4 + 3; PSA <15 ng / ml; clinical stage T1-T2a)
- Low risk of progression (Gleason score 3 + 3) only in patients who wish to leave or who refuse the active surveillance protocol and who refuse validated treatments for the treatment of organo-confined prostate cancer: radical surgery and / or radiotherapy
Key exclusion criteria (12 listed)
- Prostate cancer Gleason Score> = 4 + 4.
- Clinical stage> T2a
- PSA> 15 ng / ml
- Presence of metastases from prostate lymph node, bone or visceral carcinoma detected by bone scintigraphy, total body CT or PET-CT
- Serious coagulation disorders not correctable
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 |
|---|---|---|
| Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA)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 ablates 1800J 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 bollous of i.v. corticosteriods () is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Cirpofloxacin 500mg and gastroprotective therapy is given for 5 days. After an adequate amount of time for observation, the patient is dismissed. | Device | ECHOLASER X4 Socratelite |
Primary outcome
Disease free survival
Time frame: 5 years
Cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results in a 5 year period.
Evaluation of Complications of prostate Laser Ablation on the Treatment of Focal Low-Intermediate Risk Prostate Cancer by use of mp-MRI.
Time frame: 5 years
Evaluation of the post-procedural complications by mpMRI. In particular damage to neuro-vascular bundles, seminal vescicles and peri-prostatic fat will be checked.
1 secondary outcome
Reproducibility of mpMRI in correlation with biopsy in order to establish positive/negative predictive diagnostic values of MRI in residual/relapsing tumors
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 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 20963422Lindner U, Lawrentschuk N, Trachtenberg J. Image guidance for focal therapy of prostate cancer. World J Urol. 2010 Dec;28(6):727-34. doi: 10.1007/s00345-010-0604-9. Epub 2010 Oct 21.
- 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 1374142Costello AJ, Johnson DE, Bolton DM. Nd:YAG laser ablation of the prostate as a treatment for benign prostatic hypertrophy. Lasers Surg Med. 1992;12(2):121-4. doi: 10.1002/lsm.1900120202.
- Background: PubMed 23440319Oto A, Sethi I, Karczmar G, McNichols R, Ivancevic MK, Stadler WM, Watson S, Eggener S. MR imaging-guided focal laser ablation for prostate cancer: phase I trial. Radiology. 2013 Jun;267(3):932-40. doi: 10.1148/radiol.13121652. Epub 2013 Feb 25.
- Background: PubMed 30671638van Luijtelaar A, Greenwood BM, Ahmed HU, Barqawi AB, Barret E, Bomers JGR, Brausi MA, Choyke PL, Cooperberg MR, Eggener S, Feller JF, Frauscher F, George AK, Hindley RG, Jenniskens SFM, Klotz L, Kovacs G, Lindner U, Loeb S, Margolis DJ, Marks LS, May S, Mcclure TD, Montironi R, Nour SG, Oto A, Polascik TJ, Rastinehad AR, De Reyke TM, Reijnen JS, de la Rosette JJMCH, Sedelaar JPM, Sperling DS, Walser EM, Ward JF, Villers A, Ghai S, Futterer JJ. Focal laser ablation as clinical treatment of prostate cancer: report from a Delphi consensus project. World J Urol. 2019 Oct;37(10):2147-2153. doi: 10.1007/s00345-019-02636-7. Epub 2019 Jan 22.
- Background: PubMed 30819483Walser E, Nance A, Ynalvez L, Yong S, Aoughsten JS, Eyzaguirre EJ, Williams SB. Focal Laser Ablation of Prostate Cancer: Results in 120 Patients with Low- to Intermediate-Risk Disease. J Vasc Interv Radiol. 2019 Mar;30(3):401-409.e2. doi: 10.1016/j.jvir.2018.09.016.
- Background: PubMed 19145269Lepor H. Vascular targeted photodynamic therapy for localized prostate cancer. Rev Urol. 2008 Fall;10(4):254-61.
- Derived from this study: PubMed 38611082Manenti G, Perretta T, Nezzo M, Fraioli FR, Carreri B, Gigliotti PE, Micillo A, Malizia A, Di Giovanni D, Ryan CP, Garaci FG. Transperineal Laser Ablation (TPLA) Treatment of Focal Low-Intermediate Risk Prostate Cancer. Cancers (Basel). 2024 Apr 3;16(7):1404. doi: 10.3390/cancers16071404.
- Individual participant dataSharing planned: Yes. Create an international registry to assess long-term effectiveness of transperineal laser ablation for focal prostate cancer, 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 low-intermediate risk focal prostate cancer.
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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
Guglielmo Manenti, MD PhD principal investigator
Fondazione Policlinico Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA) in people with Prostate Cancer, 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 5 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 17 Dec 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 0620902281, gu.manenti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 5 years). 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 NCT04045756, which also lists 11 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 17 Dec 2019.