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

December 14, 2019 updated by: Guglielmo Manenti, University of Rome Tor Vergata

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00133
        • Recruiting
        • Policlinico Tor Vergata (PTV) Foundation: Department di Biomedicine and Prevention
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

42 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Investigators

  • Principal Investigator: Guglielmo Manenti, MD PhD, Fondazione Policlinico Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2019

Primary Completion (Anticipated)

August 2, 2020

Study Completion (Anticipated)

August 2, 2024

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 14, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.S. 68.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing 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.

IPD Sharing Access Criteria

Every accredited centre that performs TPLA procedures, wants to participate and signs the regulatory document and obtains ethical committee approval can participate

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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