FDA HIFU clinical trials
Due to the precision and flexibility of Sonablate HIFU, patients with their physician can decide on a customized treatment plan tailored to their prostate cancer diagnosis. Below is a summary of the different levels of customization and their clinical results.
Standard HIFU Procedure
The standard Sonablate HIFU procedure destroys the entire prostate gland. This procedure is the most appropriate choice for patients that have organ-confined prostate cancer, which is not limited to one discrete area of the prostate.
The clinical results of a standard HIFU procedure:
- 92% of patients are successfully treated1
- Over 99% of men remain continent1
- 70% of men retain erectile function1
Focal HIFU Therapy
Focal HIFU is an emerging technique for the treatment of prostate cancer, in which only the tumor is treated instead of the whole prostate gland. Focal HIFU is intended to increase the likelihood of avoiding important structures located around the prostate, which could reduce side-effects. It may be suitable for men with low- or intermediate-risk cancer who have a single tumor inside the prostate or several tumors all on the same side of the gland. Focal HIFU allows for a shorter procedure, usually 20-90 minutes, and a quicker return to normal life.
The clinical results of a focal HIFU procedure:
- 95% maintained potency (defined as return of erections sufficient for penetrative sex)2
- 89% of men achieved the trifecta status (defined as pad-free, leak-free continence, erections sufficient for intercourse and cancer control at 12 months)2
A clinician can determine if a patient is a candidate for the standard or focal Sonablate HIFU procedure. The imaging technology for the application of focal therapy is under study in a clinical trial in London, UK. The details of the INDEX trial can be found here.
Salvage Treatment with HIFU
Sonablate HIFU may be performed on patients who have previously been treated for prostate cancer and their cancer has returned, this form of treatment is often referred to as a salvage treatment. A salvage HIFU treatment can be performed on patients who have been treated with a radical prostatectomy, radiation, cryotherapy or or previous HIFU procedure. A clinician will have to determine if the patient is a candidate for salvage Sonablate HIFU.
Clinical outcomes of salvage Sonablate HIFU following external beam radiation therapy (EBRT):
- 71% biochemical disease free rate3
- 93% of men remain continent3
Sonablate HIFU may be repeated if your prostate cancer should return after a HIFU procedure. All potential side effects and complications should be discussed with a physician prior to undergoing any procedur. Please see the potential side effects section of the website for a list of possible complcations from a HIFU procedure.
Tricomin Triple Pack
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.
Does the European clinical trials directive really improve clinical trial approval time?
To facilitate and improve clinical research within Europe, the European Union (EU) adopted in 2001 the Clinical Trials Directive (EUCTD). The aim of this study was to compare duration between submission of a clinical drug trial application and approval by regulatory authorities in EU countries regulated by EUCTD vs. EU countries regulated by local legislation and, second, to compare the duration of regulatory approval in Europe vs. the USA and Australia.