We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04045756
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : December 17, 2019
Information provided by (Responsible Party):
Guglielmo Manenti, University of Rome Tor Vergata

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : August 2, 2020
Estimated Study Completion Date : August 2, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: ECHOLASER X4 Socratelite
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)
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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 ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   46 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045756

Layout table for location contacts
Contact: Guglielmo Manenti, MD PhD 39 0620902281 gu.manenti@gmail.com
Contact: Salvatore Marsico, MD PhD salvatore.marsico@hotmail.it

Layout table for location information
Policlinico Tor Vergata (PTV) Foundation: Department di Biomedicine and Prevention Recruiting
Rome, RM, Italy, 00133
Contact: Guglielmo Manenti, MD PhD    +39 0620902281    gu.manenti@gmail.com   
Contact: Roberto Floris, MD PhD    +39 0620902400    roberto.floris@uniroma2.it   
Sponsors and Collaborators
University of Rome Tor Vergata
Layout table for investigator information
Principal Investigator: Guglielmo Manenti, MD PhD Fondazione Policlinico Tor Vergata
  Study Documents (Full-Text)

Documents provided by Guglielmo Manenti, University of Rome Tor Vergata:
Informed Consent Form  [PDF] June 12, 2019


Layout table for additonal information
Responsible Party: Guglielmo Manenti, Principal Investigator, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT04045756    
Other Study ID Numbers: R.S. 68.19
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (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
URL: https://www.flaprostate.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Guglielmo Manenti, University of Rome Tor Vergata:
prostate cancer
laser ablation
interventional radiology
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases