How NOT to get your technology approved rapidly by the FDA

In a second statement to the media since an advisory panel to the U.S. Food and Drug Administration (FDA) decided not to recommend approval of EDAP TMS’s outdated form of Ablatherm technology for the treatment of low-risk prostate cancer, the company’s CEO seems to exhibit serious misunderstandings about how to work with the FDA. … READ MORE …

FDA has questions about Ablatherm HIFU device

According to a report on the Bloomberg News web site, the FDA’s reviewers appear to be less than enthusiastic about the effectiveness and safety data submitted by EDAP TMS to support approval of the Ablatherm device for use of high-intensity focused ultrasound (HIFU) for the treatment of low-risk forms of prostate cancer. … READ MORE …

Outcomes after first-line and repeat HIFU procedures in the UK

In the UK, the team led by Drs Ahmed and Emberton has been meticulous in its collection and reporting of outcome data related to their investigational use of high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer. … READ MORE …

NICE publishes guidance on focal HIFU for the treatment of localized prostate cancer in UK

In the UK, the National Institute for Clinical Excellence (NICE) has just published guidance on the use of focal forms of high-intensity focused ultrasound (HIFU) for the treatment of (low- and intermediate-risk forms of) localized prostate cancer. … READ MORE …

4-year bPFS in a series of 400+ Canadian men treated with first-line HIFU

We finally appear to have mid-term follow-up data from a sizeable series of North American patients with low- and intermediate-risk prostate cancer treated with first-line, high-intensity focused ultrasound (HIFU). The follow-up is limited to a median of 2 years, however, which allows projection of outcomes at 4 years. … READ MORE …

Korean study says that HIFU “does not provide effective oncologic outcomes”

A new paper by clinical researchers in Korea has concluded that treatment with high-intensity focused ultrasound (HIFU) “does not provide effective oncologic outcomes even in low risk patients with prostate cancer as well as in the intermediate or high risk groups,” but does have a low associated incidence of treatment complications. … READ MORE …

New data suggest that salvage HIFU after EBRT is “a high-risk procedure”

A new article reports data from two centers on experience with whole-gland high-intensity focused ultrasound (HIFU) salvage therapy for local recurrence following external beam radiation therapy (EBRT). .. READ MORE …

Further experience with salvage HIFU after first-line EBRT

A second, small study has now offered additional data on clinical experience of the use of high-intensity focused ultrasound (HIFU) as a form of salvage therapy in men initially diagnosed with localized prostate cancer, but with a rising PSA after external beam radiation therapy (EBRT) as their first-line treatment. … READ MORE …

Health-related QOL after salvage HIFU for recurrent, localized prostate cancer

Men with locally recurrent prostate cancer after first-line external beam radiation therapy (EBRT) have historically had three options for second-line treatment: salvage radical prostatectomy, salvage cryoablation, and salvage brachytherapy. … READ MORE …

Feasibility of focal HIFU: a pilot study with 10-year follow-up data

The potential of high-intensity focused ultrasound (HIFU) as a form of focal therapy for treatment of cancer isolated to a portion of the prostate as opposed to treatment of the entire prostate has been recognized for a considerable period of time. However, limited data are available so far on the outcomes of men treated with focal HIFU. … READ MORE …

Apical prostate cancer and recurrence after HIFU

The presence of prostate cancer in the apex (the lowest tip) of the prostate is always a challenging aspect for treatment of localized prostate cancer, because this places the cancer close to the nerves that control erectile function (potency) and to the sphincter (valve) that controls urine flow. … READ MORE …

Risk associated with rapid rise in PSA immediately following HIFU

An article in the April issue of Clinical Medical Insights: Oncology suggests that a rapid post-treatment increase in the PSA levels of men treated for localized prostate cancer with high-intensity focused ultrasound (HIFU) may indicate later risk for biochemical recurrence. … READ MORE …

15 years of experience with HIFU using Ablatherm technology

A media release issued by EDAP TMS SA — the developer and distributor of the Ablatherm® technology used in high-intensity focused ultrasound (HIFU) treatment of men with prostate cancer — states that a review of 15 years experience with Ablatherm technology will be published in the June issue  of Current Urology Reports. … READ MORE …

EBRT as salvage therapy for refractory or progressive prostate cancer post-HIFU

An early release paper in the Canadian Urological Association Journal offers information on a series of patients treated with external beam radiation therapy (EBRT) as salvage therapy after biochemical progression following high-intensity focused ultrasound (HIFU) as their first-line treatment. … READ MORE …

HIFU as first-line treatment in 137 Japanese patients

Data from a series of Japanese patients continue to help us to understand the risks and benefits of first-line treatment with high-intensity focused ultrasound (HIFU) for men initially diagnosed with localized prostate cancer and followed for up to 7 years. … READ MORE …