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

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01686958

Run by

Profound Medical Inc.

People needed

30

Starts

2013-03-13

Expected to finish

2019-06-11

Last updated by the study team

2020-02-11

Who can join

Age: 65 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• No cysts or calcifications > 1.0 cm in size
• No evidence of extraprostatic extension or seminal vesicle invasion
• 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

You may not qualify if…

• 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
• Additional exclusion criteria on file....

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States
• London Health Science Centre — London, Ontario, Canada
• German Cancer Research Center (DKFZ) — Heidelberg, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.