PAUL F WESLEY
Dr. Peter Sinaiko
One out of every eight men in the United States will be diagnosed with prostate cancer. Approximately one man our of 41 will die of prostate cancer making it right behind lung cancer as the leading cause of cancer deaths for men. The American Cancer Society’s estimates for prostate cancer in the United States for 2022 are 268,490 new cases of prostate cancer and about 34,500 deaths from prostate cancer. Yet, prostate cancer in its early stages is easily diagnosed and treated. Especially since doctors can check the level of a protein called prostate specific antigen (PSA), which is produced by the prostate gland. High levels of this protein call for further examination such as a biopsy or MRI.
Peter Sinaiko, MD a board-certified urologist who practices in Bucks County, says, “Before PSA testing became available, we had a test called acid phosphatase. And almost all the patients that had elevated acid phosphatase had prostate cancer that was beyond curing. PSA made it possible to find very early prostate cancers. That happened around 1990.”
Dr. Sinaiko, who did an internship in general surgery served for two years as a physician in the Air Force during the War in Vietnam, came back to the states and took a four-year residency in urology. Urology, Dr. Sinaiko explains is the treatment of male and female urinary problems and male genital problems.
Speaking about the changes in treatment for prostate cancer that happened after PSA testing came on the scene, Dr. Sinaiko says, “We were able to actually find it early. We could cure it by taking out the entire prostate or with radiation therapy. The problem was that the removing the entire prostate caused a lot of urinary incontinence and erectile dysfunction. The cure rate for radiation was similar to that of those who had surgery. But once you were treated with radiation therapy, it was very difficult to treat a recurrence.” A recurrence of cancer after radiation therapy would require what is called a salvage prostatectomy.
Dr. Sinaiko says, “A salvage prostatectomy is a miserable operation has a very high incidence of failure, incontinence and a hundred percent loss of sexual function. It was not done in robotics then. It can now be done with robots, but it's still a very difficult operation.”
A lot of these problems with both surgery and radiation can be circumvented by new treatment called HIFU, which stands for High-Intensity Focused Ultrasound. Dr. Sinaiko explains that this treatment, invented in Germany in the early to mid 1990s would destroy the prostate without taking it out. By applying focused ultrasound to prostate over 70 degrees centigrade, there’s a complete dissolution of the tissue being heated. Doctors started using this in Europe before it was ever used by American doctors. An engineer at the University of Indiana invented what Dr. Sinaiko calls the American machine, a very sophisticated machine that took 20 years to develop.
Dr. Sinaiko says, “I started using HIFU myself in 2008. At that time, it was not approved in the United States, so Americans had to go offshore to have it done. The technology was invented here, the company was located here, but you had to go offshore to actually do the treatment. So, the first 30 procedures that I performed, I did in the Bahamas.” He continues, “And overall, I guess I probably treated well over a hundred cases. After that HIFU became approved in Canada, so then I started going to Toronto and doing it there. In 2015 HIFU was finally approved in the United States. “There was a lot of opposition to it from radiation oncologists, and from robotic surgeons because they were doing robotic prostatectomies.”
Dr. Sinaiko explains that choosing patients for HIFU is a selective process. Not all patients qualify for the procedure. “We've at the point where that has gotten quite sophisticated. For instance, if I have a patient that comes in with a high PSA, the first thing I do is I get an MRI of the prostate. Because the MRI will, in many cases show the abnormality—it'll show whether it's penetrated through the outer capsule of the prostate. It's very good for finding the more malignant tumors. However, the ones that are low grade malignancy, you may not see on an MRI. So, you have to use your judgment to decide whether or not you want to proceed with a biopsy.”
HIFU can only be done if the cancer is contained and prostate gland is not greater than 3.7 centimeters. Dr. Sinaiko is able, in some cases, do a procedure that gets the prostate within size parameters. “So, when I treat these patients, if the prostate is too large, I try to shrink the prostate. That can be done with medication or I could go in and just do what's called a transoral section and just take that tissue out.”
There are two types of HIFU, one that targets only the tumors, called focal therapy and one that treats the entire prostate gland. Dr. Sinaiko doesn’t use focal therapy. “I don't do that because I don't find that there's a significant difference in outcome as far as complications between those treated with whole gland therapy and those that get focal therapy. Also doing the focal therapy could result in missing a tumor.”
There are benefits of HIFU for all concerned. The procedure is not costly and now Medicare covers it. It is less invasive and has less side effects than either surgery or radiation. “The patient gets off the table with a catheter and it stays in between seven and 10 days. And when you take the catheter out, the patient is able to urinate normally with good control and have erections to the degree that they had it before the procedure. There’s no pain—no pain. There is no need for morphine.”
The procedure is durable. “The durability of HIFU therapy is the equivalent of the radical prostatectomy.”
It is less expensive. It costs in the range of $100,000 to do a radical prostatectomy. Radiation therapy is somewhere between 60 and $75,000 dollars depending on the institution and what treatment they give. HIFU costs $8700 and the surgeon gets $900. “I am good with that,”
It is less time consuming. Unlike radiation treatments, HIFU is done with one treatment. “How long it lasts depends on the size of the prostate gland. If you measure the prostate in volume by milliliters of tissue, you can treat 10 milliliters of tissue per hour. So, most of the treatments are somewhere between three and four hours.
Also, patients who are treated with radiation and have a recurrence who would need a salvage prostatectomy and all the complications associated with it, can have salvage HIFU and avoid the operation.
Erectile dysfunction is often a problem for men, and especially men who get prostate surgery. This problem can be treated sometimes with pills, injections and with implant surgery. Dr. Sinaiko, who has been working with low intensity shockwave therapy and regenerative therapy, which harnesses the body’s natural abilities. Regenerative therapies have been documented by a study at Clemson University as being a very durable treatment for this problem.
Men would leave the country to get HIFU because they did not want the risks associated with surgery and radiation therapy, but now it has been approved by the FDA and Medicare. The problem is that few people have access to it. Dr. Sinaiko is currently the only physician in the area who has experience with HIFU. Dr. Sinaiko says, “I’m the only one in this. But I am willing to teach anybody how to do it and support them in doing it, because I feel from a patient’s standpoint it's better.”
Bob Waite is the editor of Bucks County Magazine.