We want to again make the point that treatment of localized prostate cancer with high-intensity focused ultrasound (HIFU), in the hands of inexperienced clinicians, is not necessarily as safe as some of the sales pitches might suggest. In the hands of highly experienced or highly trained HIFU practioners, with access to second- and third-generation equipment, the results may be different.
Ripert et al. report data from their experience of using HIFU to treat a series of 65 French patients over 5 years. They further state that they discontinued the use of this technique after these initial 65 patients. This is the third report we are aware of that clearly establishes that it takes significant time and experience to learn to do HIFU well — and it should be a warning to potential patients to seek out those physicians who have a clear track record of experience in using HIFU, if that is the form of treatment you are determined to have.
Unfortunately, the abstract of the Ripert paper does not provide us with an exact timeframe for this series of patients. (We suspect it must have been between about 2000 and 2007.) However, here is a summary of what they report:
- All 65 patients were treated at one center using Ablatherm equipment.
- 55 patients were treated with HIFU as their first-line treatment; another 10 patients received salvage HIFU after radiation therapy.
- A total of 74 HIFU procedures were performed in the 65 patients.
- Median follow-up was 41 months (range, 10-64 months).
- All the actual procedures were well tolerated and no deaths occurred during or immediately following the procedure.
- The early complication rate in patients undergoing first-line HIFU was 36.4 percent, and 20 percent of these 55 patients had urinary retention.
- The long-term urinary incontinence rate was 20 percent and the rate of erectile dysfunction among men who claimed to have good erectile function prior to treatment was 77.1 percent.
- The late complication rate was 12.7 percent, with urethral stenosis (blockage of the urethra) and dysuria (pain on urination) being most evident.
- The overall complication rate was 49 percent.
- Six technical incidents in use of the equipment led to discontinuation of the procedure and nine complications (16.4 percent) required surgical management.
The authors conclude that, “Ablatherm is a reliable technique with a relatively high complication rate. However, most complications were minor and required surgical management in a few cases only.” They go on to make the point that The “New” Prostate Cancer InfoLink wishes to emphasize: “Our results confirm that all patients who are offered HIFU treatment should be properly informed of the risks, in particular with regard to continence and sexual function.” [Bold italic type added for emphasis.]
There have been many men who have had excellent outcomes after treatment with HIFU, and we do not intend to leave the reader with the idea that HIFU is a dangerous form of treatment. However, it is also very clear that it takes time and experience to learn to carry out HIFU well, and that, until that experience has been accumulated, clinicians may well not be able to achieve, with reliability, the quality of outcome that the patient is expecting. Even the clinicians using HIFU in clinical trials in the USA today may have had limited training and limited experience with this technique, and potential patients are strongly advised to insist on a very detailed discussion of the individual physician’s experience before they commit to HIFU at this time.