It seems like there is a new test every few months. I’ve had a few of them as you may have seen in the archives of this blog. Now there is a 4KScore test,
A newly available commercial blood test performs better than a commonly used online risk calculator in predicting which men with an elevated prostate-specific antigen (PSA) level will ultimately turn out, on biopsy, to have high-grade disease.
According to Richard Albin, PhD, who discovered the PSA in 1970, current testing standards may indeed be a hoax.
Every year, more than a million men undergo painful needle biopsies for prostate cancer, and upward of 100,000 have radical prostatectomies, resulting in incontinence and impotence. But the shocking fact is that most of these men would never have died from this common form of cancer, which frequently grows so slowly that it never even leaves the prostate. How did we get to a point where so many unnecessary tests and surgeries are being done? In The Great Prostate Hoax, Richard J. Ablin exposes how a discovery he made in 1970, the prostate-specific antigen (PSA), was co-opted by the pharmaceutical industry into a multibillion-dollar business. He shows how his discovery of PSA was never meant to be used for screening prostate cancer, and yet nonetheless the test was patented and eventurally approved by the FDA in 1994. Now, doctors and victims are beginning to speak out about the harm of the test, and beginning to search for a true prostate cancer-specific marker.
It’s called the Artemis System or the UroNav Fusion Biopsy System with DynaCAD software, and it may be coming to a hospital or urologist near you. I had a similar procedure a few years ago at the NIH, though this research was also exploring the use of high definition MRI as a non-invasive alternative to biopsy. Will it reduce the number of false negatives for prostate biopsies or improve localization of a known tumor? We can only hope so!
“As with PCs in 1975,” said Dr. Marks, “there are some deniers, but not many once they see the dramatic results of fusion-guided biopsies. Despite the cost, the learning curve, the new technology, and the time investment, the train has left the station.”
In fact, he said that his department believes MRI-ultrasound fusion represents the gold standard for prostate biopsies today. Nationally, said Dr. Marks, urologists use MRI-ultrasound fusion in less than 1% of the 1 million prostate biopsies performed yearly. But that will change quickly, he said, as heavyweight imaging companies continue putting their marketing muscle behind the technology.”
“Abandonment of PSA testing would lead to a large increase in men presenting with advanced prostate cancer and a reversal of the gains made in prostate-cancer mortality over the past three decades,” the doctors said in the statement. Deaths from the disease have declined by more than 30 percent since testing started, they said.
Two new tests are now available that screen material from biopsy samples. One attempts to reduce the possibility of false negatives in a biopsy that had a negative result for cancer. The ConfirmMDx test essentially increases the range of a biopsy sample, allowing the laboratory to detect cancer from genetic markers in tumors that may not have been directly sampled and otherwise missed. This can reduce the need to retest in a future biopsy. From Reuters.com:
“When a prostate biopsy is performed for appropriate indications, there may be concern that the cancer may have been missed, despite the usual 10-14 core sampling. Tests which can improve the negative predictive value for a 1st time biopsy have clinically significant benefit, thus potentially avoiding unnecessary repeat biopsies,” said Neal Shore, MD, FACS, CPI, Medical Director at the Carolina Urologic Research Center. “ConfirmMDx is a valuable addition to our armamentarium and addresses an unmet need in diagnostic evaluation. Many men are subjected to unnecessary repeat biopsies, with the attendant morbidity and cost, as a result of an elevated PSA as well as the concern of missing an undetected cancer. ConfirmMDx assists in the avoidance of unnecessary repeat biopsies.”
The second test, Oncotype DX, uses genetic information on a positive biopsy result to help distinguish aggressive prostate cancer from slow growing tumors. This may help a patient and physician choose a treatment plan. From Reuters.com:
“The results of our study showed that the individual biological information from the Oncotype DX prostate cancer test tripled the number of patients who can more confidently consider active surveillance and avoid unnecessary treatment and its potential side effects. The test also identified a smaller number of patients who, despite seemingly low-risk clinical factors, had more aggressive disease and, would suggest that they consider immediate treatment,” said Peter Carroll, M.D., MPH, professor and chair, Department of Urology, UCSF and principal investigator of this validation study. “With these new study results, I believe we may be able to significantly increase the use of active surveillance, which has been limited to some extent by the absence of a validated genomic tool to more accurately distinguish low and high risk disease at the time of biopsy.“
A few months ago, I visited my uroligist again. My DRE was unchanged from previous visits. I did report some minor symptoms for the first time. An extra overnight trip to urinate now and then, for example. Every once in a while, the flow just aint what it used to be. He said there’s probably no need for treatment at this point, but if things worsen, I would consider something like Avodart, Proscar or Flomax. He also said that since my PSA has risen slightly, I should continue monitoring it every 6 months.
On the plus side, I had another PSA test this week, as I was due for a cholesterol lipid panel blood test. The level was 2.79, well within my range over the last few years.
Also, if you’re looking for information on side effects, complications and otherwise what to expect after a prostate biopsy, be sure to check out our blog on the topic and hundreds of responses from men who have reported about their procedures:
If you are older than age 55, have no previous diagnosis of prostate cancer and have a recent digital rectal exam and PSA test result, this calculator may be of interest:
Since my last PSA test over a year ago, my PSA level has risen to 3.01. My previous high was 2.9. So, not an alarming rise, but I will be seeing my urologist for an overdue annual checkup soon.
Fear is a powerful motivator to have surgery, once you have a biopsy. But, with so many unnecessary biopsies done on the basis of PSA testing, perhaps it’s time this whole system is questioned. According to new research, many men may not benefit at all from testing or surgery, depending on their situation. If you have read my blog, I think it becomes very clear that prostate biopsies are making a lot of surgeons a lot of money and lead to a lot of unnecessary surgeries, too. When will we finally get a tool for detection of these cancers that straight out of the 1950s and surgical methods that aren’t nearly as radical with fewer major side effects?
“The real point is that we shouldn’t focus on finding every prostate cancer because, as this study and all the screening studies show, the majority that you find don’t need to be found,’’ said Dr. Thompson, an author of the editorial. “What we should focus our screening on and our testing on are patients who are likely to have more aggressive tumors in which treatment seems to make a difference.”
The PSA prostate-cancer test used by half of U.S. men older than 40 carries more risks than benefits and shouldn’t be used to diagnose the disease, a U.S. panel said, reaffirming its earlier advice.
Scientific studies suggest the number of deaths avoided by screening are “very small” compared with risks from testing or treatment that can include infections, incontinence, erectile dysfunction and death, the U.S. Preventive Services Task Force said in a medical journal today. The 16-doctor panel kept its recommendation from last October after some doctors and patient groups said discouraging the tests would cost lives.
The PSA exam searches for high levels of prostate-specific antigens. In a 2010 survey, 53 percent of American men older than 40 reported taking the test in the prior two years, according to the U.S. Centers for Disease Control and Prevention.
The panel based its recommendations largely on a U.S. study of 77,000 men who were screened and a European review of 182,000. In the U.S., researchers found no evidence the test reduced deaths. The European trial found the exam lowered the mortality rate. The improvement was due solely to results from Sweden and the Netherlands, while patients in five other countries fared no better after testing, the task force said.