The New York Times has a story published last Friday about American men traveling to Mexico to receive a treatment for prostate cancer that is not approved in the United States. The article implies that this treatment is an unproven entity and may be unethical. I’m not so certain about this, so let’s take a look.
The treatment is called High-Intensity Focused Ultrasound, or HIFU. The title of the story is:
Doubts? Who’s doubting the treatment – the doctors who perform it? The company who makes the product? The patients themselves? Of course – it is physicians in America who don’t have access to the treatment who are skeptical. Such attitudes are not necessarily detrimental to the advancement of prostate cancer care; most oncologists prefer to see at least a modicum of sound clinical evidence for a new treatment before recommending it. In the matter of HIFU, however, I believe that some caveats need to be given to both sides before anyone jumps to conclusions about it being the latest example of quackery.
HIFU for prostate cancer involves sedating the patient and then using a transrectal ultrasound to destroy prostate cancer cells with temperatures in excess of 80 degrees centigrade. The controversies surrounding this procedure have been clearly listed by experts in prostate care. Here are some of them:
1. It is expensive and not covered by health insurance.
2. Patients must travel out of the country to receive it.
3. HIFU has been reported to cause the very symptoms that many patients are trying to avoid with this therapy, viz. erectile dysfunction and urinary incontinence.
4. American trials have not yet been completed, so no conclusions about the short term benefit of HIFU in American men can be made.
5. Results are not guaranteed; seven published trials show local control rates of around 70-85% – not 100%.
6. No long-term follow-up (that is, 10-20 years) has yet been published. Does the cure rate plateau with HIFU or do patients continue to relapse as the years go by?
With these doubts, why do I personally believe there are reasons for hope with HIFU? A literature search returned 259 medical articles describing HIFU for prostate cancer alone, and some of the data suggest that the treatment, with further refinement and research, may turn out to be effective.
From Japan (181 patients): The biochemical disease-free survival rates at 1, 3 and 5 years in all patients were 84%, 80% and 78%, respectively…High-intensity focused ultrasound therapy appears to be a safe and efficacious minimally invasive therapy for patients with localized prostate cancer, especially those with a pretreatment PSA level less than 20 ng/mL.”
From Germany (402 patients): The negative biopsy rate [called “HIFU failure”]observed in the T1-2 primary-care population was 87.2%…These short-term results obtained on a large cohort confirm that HIFU is an option to be considered for the primary treatment of localized prostate cancer.”
from France (227 patients): “The actuarial 5-year disease-free survival rate (DFSR), combining pathologic and biochemical outcomes, was 66%. DFSR showed a significant decrease when stratified according to initial PSA level: 90% with PSA
“Although a great deal about HIFU physics is understood, its clinical applications are currently limited, and multiple trials are underway worldwide to determine its efficacy.”
Excellent. As Nero said, “Let the trials begin.”