Atlanta, Georgia 30322


Purpose:

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.


Study summary:

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


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


NCT ID:

NCT03634579


Primary Contact:

Principal Investigator
Sherif G Nour, MD
Emory University

Sherif G Nour, MD
Phone: 404-788-3164
Email: Sherif.nour@emoryhealthcare.org


Backup Contact:

Email: kareem.elfatairy@emory.edu
Kareem Elfatairy, MBBCh


Location Contact:

Atlanta, Georgia 30322
United States

Sherif G Nour, MD
Phone: 404-788-3164
Email: Sherif.nour@emoryhealthcare.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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