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Ablatherm vs Sonablate (Page 1 of 8)
Sonablate Phase I/II Study
 The
December 2007 Journal of Urology included an article entitled “Phase
I/II Trial of High Intensity Focused Ultrasound for the Treatment
of Previously Untreated Localized Prostate Cancer” (hereinafter “Phase
I/II Trial”). It was written by Michael O. Koch, Thomas
Gardner, Liang Cheng, Russell J. Fedewa, Ralf Seip, and Narendra
T. Sangvhi—all associated with the Department of Urology
at Indiana University School of Medicine and/or Focus Surgery,
Inc., the manufacturer of the Sonablate 500 HIFU device.
The article provides a review of the study performed using
the Sonablate 500 as the first step toward trying to get
FDA approval for the device. The results portion of the study
abstract follows:
Results: A total of 19 patients had
complete followup. Serious adverse events related to
treatment were limited with the most common adverse event
being transient urinary retention more than 30 days in
duration in only 10% of patients. Rectal injury occurred
in 1 patient. With 1 to 3 treatments 42% of the patients
achieved prostate specific antigen less than 0.5ng/ml
and a negative prostate biopsy.1
If the goal of the study was to demonstrate the safety
and efficacy of the Sonablate device,2 it does
not appear that this goal was achieved. In 60% of the cases,
at least one additional HIFU treatment was required. More
importantly, even with multiple treatments, only 42% of
patients had a PSA of <0.5ng/ml and a negative prostate
biopsy; i.e., in 58% of patients the Sonablate did not
effectively treat the cancer.
Dr. Christian Chaussy, one of the most experienced physicians
using HIFU in the world, in his editorial comment on the
article, stated “According to the authors the primary
goal of the study was to document the safety of the method
and secondarily to show the potential efficacy of transrectally
delivered HIFU with the Sonablate. Neither topic shows
convincing results.” In addition, “a 5% incidence
of rectourethral fistula and a urinary incontinence rate
of 20% do not represent a low complication rate.”
Patients should compare the Sonablate results detailed
in its FDA trial study with study results using the Ablatherm
HIFU device. In a presentation to the Northeastern Sectional
meeting of the American Urological Association in September
2007, Dr. Magdy Hassouna of Toronto presented Maple Leaf
HIFU’s results using the Ablatherm:
- With a patient profile similar to the one in the Sonablate
study above (Gleason score 7 (3+4) or less, pretreatment
PSA 10 ng/ml or less, and stage T1–T2 disease),
88% of Maple Leaf patients achieved a PSA nadir of less
than 0.5 ng/ml at 3 months.
- Only 2% of the patients treated represented biochemical
(PSA nadir + 2.0) or pathological (biopsy proven local
recurrence/persistence) failures.
- The remaining 10% of patients currently show no evidence
of biochemical or pathological failure. It is probable
that the success rates for this group as a whole will
prove to be even higher than the current 88%.
Morbidity rates are similarly in favor of Ablatherm. None
of Maple Leaf HIFU’s patients has developed a rectourethral
fistula (indeed, there have been no cases of fistulae reported
worldwide since software parameters were changed on the
Ablatherm in 2002). Incontinence issues, if any, were limited
to irritative symptoms experienced during the first three
months and were resolved by six months.
The high success rate obtained by Maple Leaf HIFU mirrors
those achieved with thousands of Ablatherm treatments across
the world. The total lack of rectourethral fistulae since
2002 and the virtual absence of Type III urinary incontinence
(significantly less than 1%) are undoubtedly due to the
failsafe mechanisms on the Ablatherm (see http://hifu.ca/patient/hifu_devices.php);
the superior 7.5MHz real time ultrasound imaging; and the
computerized treatment system all of which allow for a
precise treatment plan and markedly reduce complications
and/or residual cancer associated with an operator dependent
system.
In view of the above, any patient whose urologist tries
to convince him to go to Mexico or the Caribbean to be
treated by him with the Sonablate 500 should ask his urologist
about the poor results from the phase I/II FDA study on
the Sonablate 500. He should also ask about the doctor’s
own experience treating patients with the Sonablate device
if he proposes to do the treatment himself. In addition,
he should inquire of him why he is not sending him to Toronto
to be treated with the Ablatherm in view of its obvious
superiority in eradication of cancer and considerably fewer
complications, i.e. a zero fistula rate, very low mild
incontinence rate, and considerably less than 1% severe
incontinence rate. If you would prefer to go with the Ablatherm
treatment, you can self-refer by calling 877-370-4438.
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