New Approaches to Early Prostate Cancer

Men today diagnosed with early prostate cancer, Gleason Stage 7 or less, have the option of a new arm of care called watchful waiting. With periodic PSA blood tests, prostate biopsies and imaging studies; urologists and oncologists can follow the patient with disease felt to be not aggressive rather than radiate the lesion or surgically remove it as was done in the past. In some cases, they can watch it even closer with an approach called Active Surveillance. This week a new research treatment was made public.

MedPage Today published work by Steve Raman, M.D., of the UCLA Medical Center on his TULSA-PRO ablation clinical trial. One hundred-fifteen men with localized and low, or intermediate, risk prostate cancer underwent ultrasound blasting of the cancer using the MRI imaging equipment to direct the therapy. In his study, prostate volume decreased from 39 cubic centimeters before treatment down to 3.8 cubic centimeters after a year. Clinically significant cancer was eliminated in 80% of the study participants and 65% had no evidence of cancer after biopsy at one year. PSA blood levels decreased by 95%. The side effects were minimal with low rates of incontinence and impotence and few bowel complications.

The study leader noted that if prostate cancer reoccurred then the modalities of repeat ultrasound treatment, surgery or radiation were still possible. In August 2019, the FDA approved the TULSA-PRO Device for use. The procedure involves placing a rod-shaped device into the urethra. The device has ten ultrasound probes which are controlled by a computer program while the patient is observed in an MRI machine. The probes shoot out sound waves that heat and destroy the tissue the sound is directed at. The procedure is an outpatient procedure which can also be used to shrink a non-cancerous enlarged prostate from benign prostatic hypertrophy.

Does Not Testing the PSA Lead to More Advanced Prostate Cancer?

Mortality from prostate cancer has diminished by almost 40% since the introduction of the PSA test in the late 1980’s. Much of this is due to the use of the PSA blood test for screening purposes. In 2011 The US Preventive Screening Task Force strongly condemned the use of PSA screening. They felt that we were finding too many inconsequential early malignancies that would not lead to death and were being over treated. In their eyes, prostate cancer treatment with surgery and or radiation carried a high price tag with multiple long term complications and the benefit of screening was not worth the risk. Prior to the USPSTF”s 2011 recommendation against screening for prostate cancer with a PSA there were 9000 – 12,000 new cases of prostate cancer diagnosed per month. In the month following the USPSTF recommendation not to screen with PSA the number of new cases dropped by almost 1400 a month or over 12%. Over the next year the decline in prostate cancer diagnosis was 37.9 % for low-risk prostate cancer, 28.1% for intermediate risk, 23.1 5 for high risk and 1.1% for non-localized cancer. Clearly if you do not look for a disease you will not find it.

In the December issue of the Journal of Urology, Daniel Barocas, MD, of Vanderbilt University and colleagues discussed the PSA testing controversy. They too noted that the consequences of not screening for intermediate and high risk prostate cancer by performing the PSA test may lead to individuals presenting with far more advanced disease that is more difficult to treat, has more complications and ultimately leads to disease related deaths. His position was debated by two major urologists in the editorial section of the journal with no firm conclusion being reached.

In an unrelated article, the Center for Medicare Services or CMS announced that it is considering penalizing physicians who test the PSA for screening in Medicare patients beginning in 2018 as part of their paying for value and quality. They said that physicians need to present their patients with an ABN (advanced beneficiary notice) stating that Medicare will not pay for this test, before the blood is drawn or face fines and penalties.

Men in their forties and older have been put in an uncomfortable and inappropriate position by health policy leaders. The truth is we are currently unsure how and when to test for prostate cancer in men with a normal digital rectal exam (DRE). The consequences of not paying for screening will not be known or understood for easily ten to fifteen years. It is clear that early stage disease has the option to be observed for progression with minimal consequences in the short term. Not enough time has elapsed for anyone to know the long term effects of this policy change. Unfortunately, men in this age group are all guinea pigs in the public health policy laboratory while the data to reach a firm scientific conclusion is assembled. The predominant policy today is spending less and doing less. With this in mind, it is best for men to see their doctor, have an annual digital rectal exam, discuss their family history of prostate disease and reach an individual decision on PSA screening appropriate for their unique situation rather than one based on large population policy.

Trained Dogs More Accurate Than Lab Tests for Diagnosing Prostate Cancer

Service DogIn a report to the American Urologic Association meeting last month, Gianluigi Taverna, MD, of Humanitas Research Hospital in Milan, Italy presented data that specially trained dogs outperformed available lab tests to diagnose prostate cancer. Two German shepherds were trained to recognize the smell of volatile organic substances to distinguish the smell in urine of prostate cancer from healthy individuals and those with other illnesses. The study involved 900 people including 320 prostate cancer patients. All study participants provided a urine specimen which the two dogs smelled. One dog had 100% sensitivity for prostate cancer, 97.8% specificity and 98.9 % accuracy. The 2nd dog had a sensitivity of 98.6%, a specificity of 95.9% and an accuracy of 97.3%. The researchers admit they do not know what chemical or molecule in the urine the dogs smell to achieve such dramatically accurate results. They now begin the difficult task of trying to find it and then create machines that can replicate that accuracy.

While I applaud the study and the curiosity of the researchers I believe we already have the technology available and they are called dogs. From a cost effective standpoint training more of “mans’ best friend seems to be the most cost effective way to accurately detect prostate cancer.

American Cancer Society Issues Prostate Cancer Survivor Guidelines

Prostate CancerThe American Cancer Society issued guidelines on how prostate cancer should be followed once treatment has been provided with the bulk of the responsibility falling on primary care providers. There are 240,000 new prostate cancer diagnoses in United States each year. Most of these malignancies are localized or regional disease in older men with five year survivals approaching 100%. The guidelines are quite simple. Prostate cancer survivors should have a PSA measured every six months for the first five years after treatment. After five years an annual PSA level is considered sufficient. If the PSA is increasing a referral should be made to a specialist either a urologist skilled in treatment of prostate cancer or an oncologist. An annual digital examination should be part of the regimen of all survivors of prostate carcinoma. These new guidelines are consistent with recommendations made by the Institute of Medicine and the National Comprehensive Cancer Network.

As treatment of cancer becomes more successful we can expect to see more guidelines on how to medically screen and follow survivors. The recommendation that the responsibility fall on the shoulders of primary care physicians comes at a time when the nation faces a shortage of future primary care physicians. At the same time that recommendations call for PSA evaluation every six months for the first five years in prostate carcinoma survivors, there are no recommendations to screen healthy males for prostate cancer with PSA measurements. That is a separate and distinct controversial issue.

Today’s Seniors Are Not as Healthy as Their Parents

Baby Boomer Couple, cropped

In the online version of the Journal of the American Medical Association an analysis of data compiled by the National Health and Nutrition Examination Survey ( NHANES) suggested that today’s baby boomers are not as healthy as their parent’s generation. The baby boomers, born between 1946 and 1964, may live longer but they do so with more complaints and more chronic illnesses.  The study compared the two generations at ages 46 and 64 on several health measures using the years 2007- 2010 for the baby boomers and comparing it to data they had from 1988- 1994 for the prior generation.

The demographics in the two groups indicated a larger number of Hispanics and non-Hispanic Blacks in the baby boomer generation than the previous generation.  The data in many cases was self-reported with only half as many baby boomers 13% reporting their health as “excellent” while their parents’ generation had 32% respond excellent to the same question.  The baby boomers reported that more were using walking assisted devices, more were limited in work and more had functional limitations than their parents’ generation. As a group, obesity is more common in the baby boomers (39% vs. 29%), as is high blood pressure, elevated cholesterol and diabetes.

The prior generation got more physical exercise than the baby boomers by a margin of 50% compared to 35% when asked if they were getting exercise at least 12 times per month. Smoking was more common in the prior generation.  The study authors concluded that we need to “expand efforts at prevention and healthy lifestyle promotion in the baby boomer generation.”

It is hard for me as a clinician to gain much insight from this data. Clearly the previous generation lived through a depression and fought two major wars. Their definition of “excellent” may be different than baby boomers whose expectations may be completely different from reality.

An epidemic of obesity has contributed to an increase in its associated diseases including diabetes, high blood pressure and lipid abnormalities. The goal of education and prevention is a wise one and needs to start in the preschools and elementary schools if we wish to be a healthier society

 

FDA Approves New Prostate Cancer Blood Test

The PSA blood test which has been used to screen for prostate cancer has come under a barrage of criticism in recent weeks. The PSA level increases in many non-cancer conditions and this has led to many biopsies and procedures that created more harm, and cost, than good. For this reason, the prestigious Institute of Medicine (IOM) and the U.S. Preventive Task Force have indicated that men should not be routinely screened for prostate cancer with the PSA blood test.

A new test may be on the horizon.  Beckman Coulter said its application for the Prostate Health Index test has been approved by the FDA. The test measures a PSA precursor protein known as [-2] pro-PSA in men with elevated PSA’s between the level of 4 and 10. This, coupled with the PSA and free PSA, helps create the Prostate Health Index.  The company’s data showed that by using the Prostate Health Index there were 31% fewer negative biopsies of the prostate.   The test will be commercially available by the fall of 2012.

We will make this test available when the commercial labs inform us that they are ready to perform it. It remains to be seen whether the health insurance companies will pay for it immediately.  We will need to monitor whether the promise and initial data are accurate when the test is introduced into the general public. We will also need guidelines on how often to follow this index.

Prostate Cancer Risk Can Be Predicted With a Single PSA Test

The highly acclaimed Institute of Medicine and now the U.S. Preventive Task Force have recommended against routine screening of asymptomatic men for prostate cancer. Now, a study presented by Christopher Weight, MD from the Mayo Clinic Department of Urology adds more information and confusion to the fire. Dr. Weight presented his data at a recent meeting of the American Urologic Association.

The Mayo Clinic followed men younger than 50 years old for 16.8 years.  They concluded that men at age 40 with a PSA value of less than 1ng/ml had a less than 1% chance of having prostate cancer at age 55. They had less than a 3% chance of having prostate cancer at age 60.  They concluded that men with a baseline PSA < 1% in their 40s appear to be able to safely avoid annual screening until age 55.  “Men with a baseline PSA greater than or equal to 1 have a substantial risk of subsequent biopsy and cancer diagnosis and should be followed annually.”

This is one of the first research studies to quantify the actual relationship of screening young asymptomatic individuals and the subsequent risk of developing the disease.  It is the type of research needed to help guide us to make safe and sane recommendations about the type of screening for prostate cancer and frequency of screening using blood tests, ultrasound and of course digital rectal examination to palpate the prostate. All the patients in the Mayo study received a PSA assessment, digital rectal exam and transurethral ultrasound of the prostate at study entry and biennially thereafter.

This study affirms the recommendation for performing a screening digital rectal exam on all men at age forty and subsequently. It begins to answer the question of who needs follow-up PSA testing and when.  However, more research is clearly needed.