The idea of using ultrasound for the destruction of tissue has been around for a long time but at last a company has produced a device which has gained approval in the Far East and Europe both for BPH and Prostate Cancer treatment.
Focus Surgery, a private company based in Indianapolis, Indiana, was only formed in 1996 but has developed an image-guided acoustic ablation device for the non-invasive surgical treatment of urological diseases. Focus Surgery's latest upgrade is the Sonablate® 500 System designed for the non-invasive treatment of BPH (Benign Prostatic Hyperplasia) and for prostate cancer.
Doctors worldwide have already successfully treated thousands of prostate cancer and BPH patients using the Sonablate® 500
For more information please view their web site. www.Focus-Surgery.com
The company is also looking to use the High Intensity Focused Ultrasound (HIFU) treatment for liver, kidney, pancreas, breast, cardiac, brain and cosmetic surgery applications.
The Sonablate 500
The Ministry of Health and Welfare in Japan has approved the SB-500 system for clinical use in the treatment of image-guided therapy of BPH. Based on this approval, a company has begun marketing the SB-500 in Japan.
In addition, the system received European approval with the CE 0843 mark. which includes both BPH and prostate cancer.
The drawing on the left shows the indwelling catheter with its balloon inflated to hold it in the bladder. The probe, located in the rectum, is heating up the prostate cancer cells within the prostate gland situated just below the bladder.
Narendra T. Sanghvi, president and chief executive officer of Focus Surgery, said: "These two regulatory bodies' approvals and certifications verifies our dedication to provide very high quality, state-of-the-art, minimally invasive treatment devices for the management of prostate diseases”.
HIFU is capable of destroying deep-seated tissue by rapidly elevating temperature in a precise focal zone, without affecting the intervening tissue.
Multiple site trials have already been conducted to establish the clinical efficacy in Japan, Canada and the USA; a total of seven locations with sixty two patients. Different sized probes (containing focal length transducers) are available to treat varying prostate sizes and shapes. Images produced were used for the selection of tissue volume, treatment planning and monitoring.
Patients had follow-up checks for up to two years and the results showed that HIFU was safe and efficacious for the treatment of BPH with statistically significant results and the treatment overall was found to be durable.
PROSTATE CANCER USING HIGH INTENSITY FOCUSED ULTRASOUND
The advantages of HIFU treatments are:
1) HIFU can elevate tissue temperature in the focal zone up to 70º to 90º Centigrade in a very short duration (1-4 seconds) to ablate selected cancer tissue while leaving the surrounding tissue undamaged.
2) HIFU produces sharp and predictable lesions.
3) HIFU energy is non-ionising and can be applied repeatedly.
History of HIFU Treatments of Localized Prostate Cancer.
The first group to use HIFU for prostate cancer was Marberger and others in 1994. They used the first generation Sonablate® device for 10 patients with localized prostate cancer.
Later, (1999) Gelet, treated 50 patients with 113 treatments for localized prostate cancer with a HIFU device. They reported in a two-year follow-up that the PSA level of the patients was less than 4.0 ng/ml and that they could not detect any cancerous lesions in 28 of the 50 patients treated (56%).
Three examples of more recent treatments are outlined below.
Patient #1 (78 years) diagnosed with an enlarged prostate and on ‘watchful waiting’, but after a PSA of 15.5ng/ml, had a prostate biopsy that indicated a Gleason score of 4+3 = 7. The right lobe and 1/3 of the left lobe were treated with HIFU. A pre-operative PSA level of 15.5ng/ml was reduced to 2.56ng/ml in 3 months, and then rose to 6.53ng/ml after 13 months follow up. There is a plan to treat this patient a second time with HIFU.
Patient #2 (78 years) primary complaint was of urinary retention when he was first examined in January 1999. Prostate volume was 37.9 ml. After his PSA results had risen to 13.0ng/ml, biopsies were taken, (8 in the centre and 2 from the right lobe) indicating a Gleason score of 2+2=4 giving a cancer determination, clinical stage T2a N0M0 (or stage B1) diagnosis. The whole prostate was treated during two separate treatments within the same month. A 12 month post-operative follow up showed a reduction in PSA level to 0.14 ng/ml, and no traces of cancer after biopsy exams.
Patient #3 (86 years) with stage T2aN0M0 ( or stage B1), with malignant cells determination was treated in the left lobe for 2 hrs 34 minutes. At a three month follow up after treatment, his PSA levels had been reduced from 14.4 ng/ml to 10.8ng/ml. There is a plan to treat this patient a second time with HIFU.
These patients averaged a hospital stay of only 11 days (6-20 days range) and the only complication was urethral stricture in one patient.
Usefulness of HIFU in the Treatment of Localized Prostate Cancer
The advantages of HIFU treatment for localized prostate cancer are:
1) The temperature of the focal region for prostate cancer can be considerably lower than for BPH therapy (70-80oC) and that it may shorten the total time of operation.
2) It is possible to re-treat recurrences using HIFU as many times as necessary after external irradiation, brachytherapy or cryosurgery for localized prostate cancer.
3) It is minimally invasive with no incisions to the body.
4) Overnight or outpatient treatment is possible.
5) Fewer Complications.
Dr. Uchida said: ``The patients treated with the Sonablate® show significant improvement in their PSA scores within a month of treatment and have fewer complications as compared to other prostate cancer treatment procedures. This treatment was found to be safe and has improved the quality of life for these patients.''
I was a little confused between the comment that the average stay in hospital is 11 days and yet it states that overnight or outpatient treatment is possible. The reason apparently for this is that the longer times noted are those of Dr Uchida who was taking great care not only in the treatment but also being cautious in observing the patients and testing them etc., so as to gain confidence in this new, to him, treatment.
I understand that the Japanese healthcare system favours the hotel hospital side of reimbursement. In other words, doctors make very little on surgical fees, on the other hand they keep patients in hospitals longer which makes up the difference in fees. Now this period is much lower and the average time is 1- 4 days which apparently is very short for Japan.
I am impressed that unlike all current treatments, this one can be repeated and can take place at any time. It seems it could also be used as a rescue therapy i.e. when/if existing treatments have failed. Anyone contemplating prostate cancer treatment should consider that HIFU requires no incisions so there is less chance of infection. There should be no possible damage to adjacent tissue, unlike radiotherapy for instance. And no side effects which occur with hormone treatment, although this latter treatment is unlikely to be offered to anyone with cancer cells confined to the prostate gland. (PD)
Two things to note…….
During the operation it was found that men having a suprapubic catheter had a lower rate of urethral stricture than those given a normal urethral catheter.
To date (04.07.2009) I have seen no method of telling the difference between an aggressive cancer and a non aggressive one. Often termed tiger and pussy cat cancers. The latter may never cause their host any problems at all.
This means that it is quite possible that many of those treated in the trials for HIFU, as with any other trials for that matter, would never have any problems with PC and during the annual checks would be described as clear and counted as a successful treatment.
Thought……. Are the pussycat cancers really aggressive cancers which are kept in check by a healthy immune system ? or… are the aggressive cancers, really pussycat cancers which are allowed to run wild due to a weak immune system. ? PD