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MRI Guided Prostate Cancer Focal Laser Ablation

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ClinicalTrials.gov Identifier: NCT03634579
Recruitment Status : Terminated (Lack of funding for continuation.)
First Posted : August 16, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sherif G. Nour, Emory University

Brief Summary:
The study is a prospective, single-arm, non-randomized, unblinded trial to determine the safety and efficacy of MRI guided focal laser ablation of localized low and intermediate risk prostate cancer. All subjects meeting the inclusion exclusion criteria and are enrolled will undergo a MRI guided focal laser ablation procedure. The primary aim of the study is to study the safety and efficacy of the procedure.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: MRI Guided Focal Laser Interstitial Thermal Ablation Not Applicable

Detailed Description:

Prostate cancer should be viewed as a spectrum of diseases ranging from a very indolent low-risk process to an aggressive high-risk potentially fatal disease. Active surveillance has been introduced as an alternative treatment to patients with low- risk prostate cancers.Focal therapy techniques have been introduced in prostate cancer to destroy the tumor itself with adequate safety margin with the advantage of preserving the surrounding non-cancerous tissue. Thus maintaining disease control at acceptable levels, while minimizing complications.

With the advent of multiparametric MRI (Mp-MRI), it is now possible to identify suspicious prostate gland focal lesions, determining their extent and targeting them for biopsy and focal ablation. Laser interstitial thermal therapy (LITT) is well suited for MRI environment. Laser fibers are flexible so they can fit into the MRI gantry. Laser has been shown to produce homogenous tissue necrosis that can be monitored by real time temperature maps, a feature that facilitates effective and safe ablation.

20 subjects with localized low and intermediate risk prostate cancer that meet the inclusion and exclusion criteria will be enrolled. During baseline evaluation, subjects will undergo lab tests, MR imaging, and will complete QOL questionnaires. Subsequently, subjects will undergo the Magnetic Resonance Imaging (MRI) Guided Focal Laser Interstitial Thermal Ablation procedure. Subjects will be followed immediately after the procedure, at 3 weeks, 3 months, 6 months, one year and two years after procedure for adverse events and recurrence of prostate cancer


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, Interventional, Single-Arm, Unblinded trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Resonance Imaging (MRI) Guided Focal Laser Interstitial Thermal Ablation of Localized Prostate Cancer
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: MRI-guided focal laser ablation
Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
Device: MRI Guided Focal Laser Interstitial Thermal Ablation

The procedure is done under general anesthesia. Laser fiber placement will be performed by one of two approaches (Trans gluteal or trans rectal) based on the target location within the prostate gland. When the needle position is deemed satisfactory, a 1.5-cm-active tip diode laser fiber will be introduced within an internally cooled catheter through the introducing sheath.

The catheter tip location will be confirmed on Turbo Spin-Echo (TSE) T2-weighted images in the axial and sagittal oblique planes.The introducer sheath will be withdrawn to allow contact of the active laser tip with the lesion. A laser test dose will be done at 9 Watts for about 30 seconds to confirm the site of fiber placement with the subsequent delivery of full dose ablation at 12-27 Watts. Ablation duration is determined based on real time feedback of response using real time temperature and damage estimate maps.





Primary Outcome Measures :
  1. Number of recurrences of Prostate Cancer at the end of 1 year among the subjects treated with MRI Guided Focal Laser Interstitial Thermal Ablation [ Time Frame: Up to 12 months ]
    Efficacy is assessed by recurrence rate at 1 year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation

  2. Percentage of grade 3 or higher complications as defined as National cancer institute's common toxicity criteria version 4 among the subjects treated with MRI Guided Focal Laser Interstitial Thermal Ablation [ Time Frame: Up to 24 months ]
    Safety is assessed by percentage of grade 3 or higher complications or adverse events (AE) as defined as National cancer institute's common toxicity criteria version 4: incontinence or urinary retention necessitating surgical intervention or new-onset erectile dysfunction not responsive to medication.Grade refers to the severity of the AE. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.Grade 2 Moderate; minimal, local or non invasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

  3. Change in erectile function [ Time Frame: Baseline 3 weeks, 3 months, 6 months, one year and two years ]
    Change in erectile function will be summarized at baseline and at each follow-up visit using Quality of Life (QoL) assessments - Sexual Health Inventory For Men (SHIM) assessment for erectile function. There are 5 questions and each question has 5 possible responses. The SHIM score characterizes the severity of the patient's Erectile Dysfunction (ED) in the following manner: 22-25 No ED; 17-21 Mild ED; 12-16 Mild-to-moderate ED; 8-11 Moderate ED; 5-7 Severe ED. If the patient's score is 21 or less, erectile dysfunction (ED) should be addressed.

  4. Change in urinary function [ Time Frame: Baseline 3 weeks, 3 months, 6 months, one year and two years ]
    Change in urinary function will be summarized at baseline and at each follow-up visit using Quality of Life (QoL) assessments - International Prostate Symptom Score (IPSS) assessment for urinary function. The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).


Secondary Outcome Measures :
  1. Number of recurrences of Prostate Cancer at the end of 2nd year among the subjects treated with MRI Guided Focal Laser Interstitial Thermal Ablation [ Time Frame: Up to 24 months ]
    Efficacy is assessed by recurrence rate at end of 2nd year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Patients with primary organ confined prostate cancer (≤T2c) and Gleason score ≤4+3=7

    • Lesions visible on multiparametric MRI and subsequently diagnosed by targeted MRI guided biopsy

Exclusion Criteria:

  • Multifocal intra-prostatic disease, defined as the presence the presence of ≥ 3 non- contiguous pathologically proven foci of cancer.
  • Gleason score >4+3=7.
  • Extracapsular spread.
  • Nodal or distant metastasis
  • Contraindications to MRI or general anesthesia.
  • Uncorrectable Coagulopathy.
  • Refusal of participation.
  • Lesions not visualized on the multiparametric 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): NCT03634579


Locations
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United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Sherif G Nour, MD Emory University

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Responsible Party: Sherif G. Nour, Associate Professor of Radiology, Emory University
ClinicalTrials.gov Identifier: NCT03634579     History of Changes
Other Study ID Numbers: IRB00094958
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sherif G. Nour, Emory University:
Cancer/Carcinogenesis
Laser Treatment
Magnetic Resonance Imaging (MRI)
Radiology
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases