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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: MRI Guided Focal Laser Interstitial Thermal Ablation||Not Applicable|
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
|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)|
|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|
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.
- 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
- 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.
- 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.
- 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).
- 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
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
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Sherif G Nour, MD||Emory University|