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Investigational Study For the Treatment of Localized (T1c/T2a) Prostate Cancer With High Intensity Focused Ultrasound (HIFU) Using the SonablateĀ® 500 (SB-500) System in Canada


Phase 4
40 Years
80 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Investigational Study For the Treatment of Localized (T1c/T2a) Prostate Cancer With High Intensity Focused Ultrasound (HIFU) Using the SonablateĀ® 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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA level

Outcome Time Frame:

PSA level at 30 and 90 days post treatment

Safety Issue:

No

Principal Investigator

George Vrabec, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abbotsford Regional Hospital Cancer Center

Authority:

Canada: Health Canada

Study ID:

USHIFU-CABC-PC002

NCT ID:

NCT00573586

Start Date:

Completion Date:

March 2009

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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