Investigational Study For the Treatment of Localized (T1c/T2a) Prostate Cancer With High Intensity Focused Ultrasound (HIFU) Using the Sonablate 500 (SB-500) System in Canada
Inclusion Criteria:
- Male patients with an initial presentation of organ confined prostate
cancer;(clinical stages T1c and T2a only)
- Age 40 yrs. and older up to and including age 80 yrs.;
- Anesthesia SUrgical Assignment (ASA) categories I, II or III only;
- PSA levels equal tyo or less than 10ng/ml;
- Pre-HIFU Gleason score equal to or less than 7;
- Clearly imageable prostate on TRUS;
- Prostate total volume less than 40cc with an AP height less than or equal to 4.2cm.
(If volume is greater than 40cc or height greater than 4.2 cm, one 3 monthly shot of
an LHRH analogue may be provided, followed by re-imaging of the prostate to document
total volume below 40cc).
Exclusion Criteria:
- Large calcification in the area to be treated (>5mm);
- Bleeding disorder as determined by abnormal prothrombin time (INR) and partial
thromboplastin time (PTT);
- Pt. on Coumadin or any other anticoagulent, unless their anticoagulation an be
temporarily reversed or stopped;
- Urinary Tract infection unless treated satisfactorily by antibiotics and documented
by a sterile urine culture;
- Interest in future fertility;
- History of allergy to latex;
- Inability to visualize the prostate tissue adequately on transrectal ultrasound
imaging;
- History of treatment for prostate cancer (except for one LHRH analogue "shrinkage
shot");
- History of TURP, thermotherapy or urethral stent;
- History of any major rectal surgery;
- History of inflammatory bowel disease;
- History of urinary bladder neck contracture;
- History of any other malignancy other than skin cancer. Patients that have had a
previous malignancy and no recurrence of that malignancy within the past 5 years will
be allowed; (superficial bladder cancer is OK of clear for 2 years)
- Inability to be placed in lithotomy position;
- Prior long term hormonal therapy for prostate cancer (including bilateral
orchiectomy).