Patient Choice and the Effectiveness and Safety of HIFU
An interesting article has just been published in the Journal of Urology which helps to provide information (and context) about the quality of data supporting the use of high-intensity focused ultrasound (HIFU) in the treatment of prostate cancer. This article by Babalola et al. comes from staff at the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA).
Although HIFU was approved relatively recently for “prostate tissue ablation”, it has never been approved in the US for the treatment of prostate cancer.
The authors report their findings from a detailed literature search (inclusive of all reports submitted to the FDA) that addressed:
- The effectiveness and safety of HIFU
- When used in the first-line treatment of localized prostate cancer
- When used as a form of second-line, salvage therapy in the management of localized prostate cancer
- When used either within the US or elsewhere
- Patient preference information (PPI) on HIFU-related safety and effectiveness outcomes
Their findings were as follows:
- There are “no HIFU effectiveness data relevant to clinical decision-making such as overall survival or prostate-cancer-specific survival in the US.”
- “Long-term effectiveness data from outside the US are sparse and outcomes are variable.”
- There are “no patient preference data on HIFU treatment in men with prostate cancer.”
Your sitemaster would generally agree with these findings (although he is aware he may not have seen all of the data presented to the FDA because some of those data may be confidential).
Babalola et al. conclude that
The lack of long term HIFU oncological data in a United States population has brought new challenges to prostate cancer stakeholders including clinicians, patients, and the FDA. PPI from future patient studies on HIFU could provide additional information to patients, clinicians, and current and prospective device developers.
They further note that if such data existed it could “be used by regulators in their risk-benefit evaluation for this class of treatment devices.”
The message to the developers and marketers of HIFU technology — and to the patients who are interested in seeing such technology approved for the treatment of prostate cancer — is a clear one: “Bring us sound data and we will consider it.” Such data could specifically include data on patients’ willingness to opt for treatment with HIFU over other management options (i.e., PPI), which might include active surveillance, radical prostatectomy, radiation therapy, and other forms of management if the information provided to patients had been presented in a well-structured, well-documented, and neutral manner.
In other words, the FDA appears to be willing to consider approval of HIFU for the treatment of localized prostate cancer if it can be demonstrated that sufficient numbers of patients would select such a treatment option over other accepted forms of management when it is presented as one of several possible management options with the relevant supporting data.
This is actually — in the opinion of your sitemaster — a very interesting development. The “New” Prostate Cancer InfoLink has long advised selected, individual patients that HIFU might be an appropriate management option for them, while simultaneously cautioning that the long-term data on effectiveness and safety of this form of treatment has been less than entirely compelling. We believe in the right of patients to make the best decision about management and treatment for prostate cancer that “works” for them as individuals. If it can be shown that a sufficient percentage of newly diagnosed patients would choose HIFU as their first-line management option over other forms of therapy based on the currently available data, then patients should have the right to be treated that way — so long as they also appreciate that (a) it doesn’t always work and (b) it can have some significant side effects.
And, as always, in addressing this issue, we would point out that it takes skill, training, and experience to learn to use HIFU really well. Any patients who wants to consider HIFU as a form of treatment for localized prostate cancer would be wise to discuss this with one of the relatively small number of specialists who have been well trained and who have had time to develop their skill and experience in the use of this technique.
If you are considering HIFU treatment for prostate cancer CyberKnife Radiosurgery may be a better option for you. CyberKnife has a 98% success rate for prostate cancer, it is truly non-invasive, no anesthesia, no cutting, no pain, no catheter, little to no side effects and no down time. See what our patients are saying and visit our website at www.prostatecancertreatmentmiami.com or contact us to set up a consultation with one of our board-certified radiology oncologists. Call us today at 305-279-2900