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

Profound Medical

Status

Completed

Conditions

Prostate Cancer

Treatments

Device: MR-Guided Transurethral US Ablation of Prostate Tissue

Study type

Interventional

Funder types

Other

Identifiers

NCT01686958

DOC-10246

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Male

Ages

65 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male, age ≥65
Patient with low-risk, early-stage organ-confined prostate cancer (Stage T1c or T2a, N0, M0).
Gleason score 6 (3+3)
Prostate-specific antigen (PSA) ≤ 10 ng/ml
Eligible for MR imaging (DOC-10252)
Meets the following criteria on pre-treatment transrectal ultrasound imaging:
1. No cysts or calcifications > 1.0 cm in size
2. No evidence of extraprostatic extension or seminal vesicle invasion
3. Overall prostate size less than 5 cm in sagittal length and less than 7 cm in diameter
Biopsy confirmed adenocarcinoma of the prostate, performed at least 6 weeks prior to and no more than 6 months prior to the scheduled treatment.
Eligible for General Anesthesia, as defined in American Society of Anesthesiologists (ASA)
Normal rectal anatomy and rectal mucosa on digital rectal examination

Exclusion criteria

Bleeding disorder
Abnormal coagulation and current anticoagulant therapy.
Acute or chronic Urinary Tract Infection
Interest in future fertility
History of allergy relevant medication or other
History of any other malignancy other than skin cancer
Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
Prior treatment of the prostate gland
Prior treatment with 5 alpha reductase inhibitor allowed (not as prostate cancer treatment or prevention) as long as drug has been stopped for minimum 3 months
History of any major rectal or pelvic surgery
History of ulcerative colitis or other chronic inflammatory conditions affecting rectum
History of documented clinical prostatitis requiring therapy within previous 6 months
History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae which had required prior urethrotomy, urethral stenting, urethroplasty or chronic indwelling urethral catheter
Patients with artificial urinary sphincter or any penile implant (metallic or non-metallic)
Neurologic bladder disorders
Untreated bladder stones
History of acute urinary retention
Confirmed or suspected bladder cancer
Urinary sphincter abnormalities
Active untreated gross hematuria for any cause
Post Void Residual (PVR) bladder volume > 250 mL
Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder