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Spots Global Cancer Trial Database for Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer

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Trial Identification

Brief Title: Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer

Official Title: Phase 1 Study: A Prospective, Multi-center, Single Arm Study - Evaluation of the Safety and Feasibility of MRI-guided Transurethral Ultrasound Therapy for the Ablation of Prostate Tissue in Patients With Localized Prostate Cancer

Study ID: NCT01686958

Conditions

Prostate Cancer

Study Description

Brief Summary: This study is to evaluate that the magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system is safe and feasible to ablate prostate tissue in men with localized prostate cancer.

Detailed Description: Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system. The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue. The treatment is conducted completely within an MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland, thereby reducing the risk of possible damage to important surrounding anatomy such as the rectum, urinary sphincters, neurovascular bundles and pelvic bone. This coagulation method, therefore, has the potential to have lower complication rates than conventional therapies.

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

William Beaumont Hospital, Royal Oak, Michigan, United States

London Health Science Centre, London, Ontario, Canada

German Cancer Research Center (DKFZ), Heidelberg, , Germany

Contact Details

Name: Joseph Chin, MD

Affiliation: London Health Science Center

Role: PRINCIPAL_INVESTIGATOR

Name: James Relle, MD

Affiliation: William Beaumont Hospitals

Role: PRINCIPAL_INVESTIGATOR

Name: Ryan Berglund, MD

Affiliation: The Cleveland Clinic

Role: PRINCIPAL_INVESTIGATOR

Name: Heinz P Schlemmer, MD

Affiliation: German Cancer Research Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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