The June issue of Life Extension reviewed a new prostate cancer treatment. Prostate cancer affects about 180,000 men per year and 28,000 die every year from prostate cancer metastases. Dr. Gary Onik, interventional radiologist in Ft. Lauderdale, FL, developed a new prostate cancer treatment protocol. Two years ago he published a medical paper about a 10-year follow-up on a group of 70 prostate cancer patients who had been treated by him.
New prostate cancer treatment protocol
Usually it is a rising prostate specific antigen test (PSA) that tells the treating physician that not all is well with the patient’s prostate gland. In the last two years a new more specific and very sensitive genetic screening test has been developed, called Oncoblot test. If this is positive for prostate cancer, it is almost as good as a prostate biopsy that shows the cancer cells directly. But at this point the medical profession does not accept the Oncoblot test as being proven reliable despite the fact that the FDA has approved it for cancer screening.
The gold standard: a transrectal prostate biopsy has been considered the “gold standard” for the last several decades. However, 14 years back Dr. Onik decided to develop a more meaningful and more reliable prostate mapping biopsy. With this 3-dimensional mapping biopsy the examiner inserts many biopsy needles through the perineum, the skin between the base of the scrotum and the anus. The location of the needles are carefully kept track of and sent to the pathologist for histological analysis. This way the biopsy results can be projected as a 3-dimensional image of the prostate cancer on a computer screen. This becomes the basis for the next step in the treatment protocol.
Cooling probes are introduced through the perineum and placed exactly where the prior prostate mapping biopsy located the cancer. It is this closely controlled placement of the treatment probes that ensures a much higher treatment success rate compared to the “gold standard” of the robotic prostatectomy (removal of the prostate gland).
The patient is followed up with PSA blood tests at 3-monthly intervals until the level is low and stable. Should there be any rise in PSA the patient is reexamined with another prostate mapping biopsy and treatment may have to be repeated until the PSA is low or negative again.
10-year follow-up of 70 men with prostate ablation therapy
Dr. Onik followed 70 prostate cancer patients using the above protocol for a total of 10 years. The patient’s age was between 45 and 77 years at he time of surgery. 66 of Dr. Onik’s patients survived until the end of 10 years. The four who passed away, died of causes other than prostate cancer making the “disease-specific” survival rate 100%. PSA stability was achieved in 89% of the patients.
High risk and low risk survival data with new prostate cancer treatment
Prostate cancer patients can be classified into high-risk, medium-risk and low-risk. This is done based on the histological characteristics of the cancer, the Gleason score (a measure of how aggressive the cancer is), the stage (based on the extend of the cancer) and the height of the PSA level.
Using conventional treatment (prostatectomy) long-term follow-up data show that low-risk patients have a disease free survival of 85%, while high-risk prostate cancer patients have a success rate of only 45%.
In contrast to this Dr. Onik’s protocol achieved a biochemical disease-free survival of 90% for low-risk patients, 88% for medium-risk patients and 89% for high-risk patients. Surprisingly there seems to be no difference with regard to the long-term outcome of any of the risk levels. This is unique for the Onik method of focal cryoablation therapy.
What is focal cryoablation therapy, the new prostate cancer treatment?
The prostate cancer is frozen much like a wart is frozen by liquid nitrogen treatment in the doctor’s office. In the case of prostate cancer ablation liquid Argon is used for freezing. The application is closely controlled temperature wise using heat probes to ensure adequate freezing. Special cooling probes are brought to the cancer areas that were identified by the prostate mapping procedure beforehand. The freeze/thawing is done three times. This way a 100% kill of all of the cancer cells is achieved at the time of the procedure. The treatment for every patient is individually geared to his condition.
Comparison of focal ablation treatment with traditional prostatectomy
After 5 years of prostate mapping biopsies Dr. Onik published a study where he looked at 180 men who had been diagnosed with prostate cancer on one side of the prostate gland by standard rectal biopsies. When he did mapping biopsies involving the whole prostate gland he noticed the following:
1% (110 patients) had cancer on both sides of the prostate
7% (41 patients) who had been classified having a cancer with a low-grade score increased to an intermediate-grade score
4% (35 patients) had cancer growth in very close proximity to either nerve bundles or blood vessels.
69.4% of those patients who had been diagnosed as having only low-grade, one-sided tumors were found to have more extensive cancers. With the previous classification they were thought to need only active surveillance (also known as “watchful waiting”). But with the detailed mapping biopsy results they now had at least one finding that reclassified their disease to requiring a more aggressive cancer treatment protocol. Other physicians have found the same thing when looking at these patients with more sensitive MRI scans. The prostate cancers were more extensive than when depicted with simple MRI scans. In some patients where areas on one side of the prostate seemed free of cancer using traditional MRI’s, now showed cancer on both sides using the more sensitive MRI scanners. Also using blind rectal biopsies, which is the standard technique that most radiologists use, can often miss prostate cancers that are found with sensitive MRI scanners or Dr. Onik’s mapping biopsy.
Complication rate with new prostate cancer treatment
The recurrence rate of prostate cancer treated with cryotherapy ablation therapy after 10 years was only 4%. Compare this to a study where prostate cancer was treated with radiotherapy. After 10 years the biochemical disease free survival for low risk patients was 78%, for medium risk 78% and for high risk 62%. This translates into cancer recurrences of between 22% and 38% depending on the risk stratification. The so-called golden standard procedure (robotic prostatectomy) showed the following: in a study that went on for 5 years there was a 28% overall recurrence rate. When the margins of the prostatectomy were examined, the following amounts of cancer had remained: 23% for low risk patients, 29% for medium risks and 42% for high risks.
Urinary continence was maintained in 100% of the cases meaning that the nerves going through the prostate gland were preserved.
Only 6% of patients treated with ablation therapy had problems with sex 10 years after the procedure. This compares favorably with the other treatment modalities that have much higher rates of sexual problems.
Overall cryoablation therapy is very well tolerated and removes tumor tissue exactly where the 3-D mapping biopsy findings show the prostate cancer to be located. This helps the patients’ survival rates.
Conventional treatment failures versus the new prostate cancer treatment
What are the reasons for treatment failures with conventional prostate cancer?
Blind prostate cancer biopsies are generally trans-rectal procedures. They lead to infections of the prostate, in rare cases even to blood poisoning (septicemia), but they often miss cancers that are present when mapping biopsies are done. With rectal biopsies only 8 to 16 biopsies are done. They are blind, the physician does not know exactly where the biopsies came from. With the mapping biopsies the doctor keeps track carefully where the biopsies originated from and they are sent separately to the pathologist. With the mapping biopsy 60 to 90 biopsies are taken depending on the size of the prostate gland. There is a much higher resolution of the area where the prostate cancer is located. This helps the physician where to focus the cryoablation treatment.
Poor diagnostic tests prior to cancer surgery lead to missed prostate cancer removal, which in turn lead to recurrences. Total prostatectomy (robotic prostatectomy) is not total, but only 70% are removed, leaving chunks of prostatic tissue behind. Often it is there where undiagnosed prostate cancer is left behind. This explains the poor 5-year follow-up results of 23% to 42% recurrence rates after the “gold standard prostatectomy”.
Only the mapping biopsy that depicts the entire prostate gland (which is done perineally to prevent infection) can show exactly where the cancer is located. This is subsequently removed in its entity.
The cryoablation therapy is likely stimulating the immune system to send killer T cells to help with the destruction of any remaining cancer cells. This may partially explain the low 10-year recurrence rate of only 4%.
New Prostate Cancer Treatment
Conclusion
Dr. Onik, an interventional radiologist from Ft. Lauderdale, FL, has developed a new focal ablative prostate cancer treatment. He showed in a study going on for 10 years that it is superior to either radiotherapy or robotic prostatectomy. With the baby boomers aging and prostate cancer being a disease of aging men, this has just arrived in time to be beneficial to any man who is diagnosed with prostate cancer. Most patients are suspected to have prostate cancer when their PSA value gets elevated above 4 or 5. Instead of taking a risk of blood poisoning with E. coli or developing prostatitis from the transrectal biopsy approach, the patient may want to consider having the 3-dimensional mapping biopsy done by Dr. Onik in Ft. Lauderdale. This is done through the perineal approach, which shows the exact location of the cancer. Using cryotherapy probes with liquid Argon the cancer is focally treated, which is similar to a lumpectomy in a woman with early breast cancer. Cancer recurrence rates at 10 years were only 4%. The good news is that a mapping biopsy of the prostate can be repeated, if rising PSA levels should occur in future. This shows whether there is a cancer recurrence, and this can be treated again with cryotherapy. The future will see more physicians embrace this method, as several centers are being planned in the United States. They will very likely replace a “gold standard” of prostate cancer treatment that is less than perfect.