MRI Guided Prostate Cancer Focal Laser Ablation

NCT ID: NCT03634579

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-03-15

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.

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRI-guided focal laser ablation

Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.

Group Type: EXPERIMENTAL

MRI Guided Focal Laser Interstitial Thermal Ablation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Sherif G. Nour

Associate Professor of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherif G Nour, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00094958

Identifier Type: -

Identifier Source: org_study_id