Focal Laser Ablation for the Treatment of Focal Low-Intermediate Risk Prostate Cancer

NCT04045756 | Unknown FDA Device

• 1 other identifier: R.S. 68.19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; laser ablation; mpMRI; interventional radiology

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  5 years

Study Arms (1)

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.

Device: Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA)

Interventions

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.

ECHOLASER X4 Socratelite

Eligibility Criteria

• Age: 46 Years - 86 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Policlinico Tor Vergata (PTV) Foundation: Department di Biomedicine and Prevention

Rome, RM, 00133, Italy

RECRUITING

Related Publications (11)

• 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

• Lindner 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.

  PMID: 20963422 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, 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.

  PMID: 1374142 BACKGROUND

• Oto 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.

  PMID: 23440319 BACKGROUND

• van 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.

  PMID: 30671638 BACKGROUND

• Walser 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.

  PMID: 30819483 BACKGROUND

• Lepor H. Vascular targeted photodynamic therapy for localized prostate cancer. Rev Urol. 2008 Fall;10(4):254-61.

  PMID: 19145269 BACKGROUND

• Manenti 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.

  PMID: 38611082 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Guglielmo Manenti, MD PhD

  Fondazione Policlinico Tor Vergata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guglielmo Manenti, MD PhD

CONTACT

39 0620902281; gu.manenti@gmail.com

Salvatore Marsico, MD PhD

CONTACT

salvatore.marsico@hotmail.it

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: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: August 6, 2019
• Study Start: August 2, 2019
• Primary Completion: August 2, 2020
• Study Completion: August 2, 2024
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: This registry will be open for inclusion for five years. Since individual patients will have a follow-up of five years, the total study duration will be 10 years.
• Access Criteria: Every accredited centre that performs TPLA procedures, wants to participate and signs the regulatory document and obtains ethical committee approval can participate

Locations

IT (1)