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Transperineal Laser Ablation for Focal Treatment of Prostate Cancer (TPLA for PCa)

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: NCT04170478
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : May 15, 2020
Sponsor:
Collaborators:
Elesta S.R.L.
VU University Medical Center
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Prof.dr. H.P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

Rationale: Prostate cancer (PCa) is the second cause of cancer-related deaths for men. The standard surgical treatment for localised prostate cancer is radical prostatectomy. Possible side effects of this treatment are incontinence and erectile dysfunction and this is related to the whole-gland resection. A focal treatment with fewer side effects is desired for patients with only a small focus of PCa. For this purpose, focal laser ablation is feasible. Current focal laser ablation techniques use a single fibre setup with the need for fibre replacement revisualisation of the tumour side accordingly. This leads to a long treatment duration.

The Echolaser® system is a laser ablation system with four simultaneously operating laser sources. This provides a potential larger treatment area, without the need for fibre replacement.

This makes the system advantageous for focal laser ablation of prostate cancer, especially since it can be applied under local anaesthesia.

This pilot study aims to evaluate histological ablative efficacy on radical prostatectomy specimens following TPLA, feasibility and safety using a (multi)fibre setup in men with localized prostate cancer. The investigators hypothesize that TPLA will show adequate histological ablative efficacy and will be feasible and safe.


Condition or disease Intervention/treatment Phase
Prostate Cancer Focal Laser Ablation Transperineal Laser Ablation Device: Echolaser X4 system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy Evaluation Using Postradical Prostatectomy Histological Analysis
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • Device: Echolaser X4 system
    Transperineal laser ablation


Primary Outcome Measures :
  1. Ablative efficacy of transperineal laser ablation determined by size of the ablation zone in histopathology, which is measured by absence of vital prostatic cells, compared to the size measured on imaging (CEUS/MRI) during and after treatment [ Time Frame: 30 days following TPLA treatment ]
    Histological ablative efficacy is assessed on histopathological analysis of the prostatic tissue after radical prostatectomy by means of the absence of vital cells in the treated prostate zone


Secondary Outcome Measures :
  1. Safety is assessed by device and procedural adverse events using the CTCAEv5.0 until radical prostatectomy and feasibility is determined by procedural success of the TPLA treatment. [ Time Frame: 30 days following TPLA treatment ]

    Safety is assessed by device and procedural adverse events using the CTCAE v5.0 until radical prostatectomy. TPLA is definitely safe when ≤10% of patients experience major adverse events, defined as grade 3 or higher. Technical feasibility is determined by procedural success of the TPLA treatment.

    TPLA is definitely feasible when ≥90% of procedures is performed successfully without any problems regarding needle placement, fibre introduction or device malfunctioning.


  2. Size of ablation zone [ Time Frame: 30 days following TPLA treatment ]
    Determination of the size of the ablated area

  3. Observation of tissue changes seen on imaging during and after treatment compared to histopathology [ Time Frame: 30 days following TPLA treatment ]
    Ablation zone volumes are measured using CEUS and mpMRI and these are used to determine ablation zone compared to histopathological changes. Visual changes are identified and described.

  4. Functional outcomes measured using PROMs (VAS, IPSS, IIEF-15, EPIC) [ Time Frame: 30 days following TPLA treatment ]
    Determination of short-term functional outcomes following TPLA treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • ≥40 years of age
  • Histopathological confirmed organ-confined prostate cancer
  • Indication for a radical prostatectomy
  • Prostate volume ≥40 mL
  • Ability of the patient to stop anticoagulant therapy prior to TPLA according to standard hospital pre-operative protocol
  • Signed informed consent

Exclusion Criteria:

  • Refusal of participation or clinically ineligible for treatment under local anaesthesia
  • Prior or concurrent treatment for prostate cancer
  • Other conditions / status

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): NCT04170478


Contacts
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Contact: J R Oddens, MD, PhD +31 20 5668637 j.r.oddens@amsterdamumc.nl
Contact: L A van Riel, MD +31 20 5664820 l.a.vanriel@amsterdamumc.nl

Locations
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Netherlands
Academic Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Contact: J R Oddens, MD, PhD    +31 20 5668637    j.r.oddens@amsterdamumc.nl   
Contact: L A van Riel, MD    +31 20 5664820    l.a.vanriel@amsterdamumc.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Elesta S.R.L.
VU University Medical Center
The Netherlands Cancer Institute
Investigators
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Principal Investigator: J R Oddens, MD, PhD Urologist
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Responsible Party: Prof.dr. H.P. Beerlage, Head of Urology department, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT04170478    
Other Study ID Numbers: 2019_161
NL69903.018.19 ( Other Identifier: Toetsingonline )
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof.dr. H.P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Prostate Cancer
Transperineal laser ablation
Prostate neoplasma
Focal laser ablation
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases