Part 3 – Prostate Cancer: Making Sense Of The Prostate Cancer Screening Controversy

The controversy regarding prostate cancer screening can be overwhelming.  Screening is the process by which one tries to identify a disease, such as prostate cancer, when someone is without symptoms.  The goal is early detection, which may lead to improved survival.  Screening for prostate cancer is accomplished using the PSA blood test and digital rectal examination.  The PSA value should be less than 4 to be normal.  However, in reality, a normal PSA varies by age, with lower values for younger men, and higher values for older men.  The digital rectal examination surveys the prostate for tumors.

Why does the United States Preventative Services Task Force recommend against PSA-based screening for prostate cancer?  The USPSTF is a group of government-appointed primary care physicians whose charge is to determine whether or not a test is beneficial.  In the case of prostate cancer, they made their decision based on two clinical trials, one conducted in Europe, and the other in the United States.  The goal of the studies was to determine if prostate cancer detected by PSA and digital rectal examination led to improved survival.  The US-based study had many flaws, which invalidated the findings. The European based study demonstrated a survival benefit of 21% 13 years after treatment.  Thus, prostate cancer screening, and subsequent treatment, does improve survival.

The controversy results from the varied nature of prostate cancer.  The majority of prostate cancer diagnosed in the US is slow growing and non-aggressive.  These men die WITH, NOT OF, prostate cancer.  In other words, it has no effect on their survival, even if not treated.  However, there are men who have aggressive prostate cancer.  Men with these types of tumors benefit from treatment.  Prostate cancer is the second leading cause of cancer death in American men, with approximately 30,000 men succumbing to the disease every year.  The goal of prostate cancer screening, then, is to determine not just if you have prostate cancer, but if you have the dangerous, aggressive, form.

One of the concerns regarding prostate cancer screening has been the risk of infection with prostate biopsy.  Recently, tests have been developed to risk stratify men that may have aggressive prostate cancer, minimizing the risk of infection to those men who are unlikely to benefit from biopsy.  The Opko 4KScore Test, for example, is designed to identify those men that are more likely to harbor “clinically significant” prostate cancer.  These men are most likely to benefit from identifying their prostate cancer.

What makes the prostate cancer screening controversy challenging, and frustrating, is that there is no straight answer.  The decision to undergo prostate cancer screening is nuanced and personal.  The American Urological Association recommends that men discuss prostate cancer screening with their doctors.

We would be happy to sit down with you and discuss this in greater detail, helping you determine whether or not screening make sense for you. 

Please call our office to schedule an appointment (480) 394-0200.

Part 2 – Prostate Cancer: Is Prostate Cancer Screening Right for You?

As discussed in last month blog, prostate cancer screening is controversial. How do you know if it’s right for you? The American Urological Association recommends that all men between the ages of 55 and 69 have a discussion with their doctor regarding the risks and benefits of prostate cancer screening, taking into account each man’s individual situation. Men who are African American, have a family member afflicted with prostate cancer, or have worsening problems with urination are at higher risk of developing or harboring prostate cancer. These men should consider beginning screening at an earlier age, and as needed if urinary symptoms are present.

Harms associated with prostate cancer screening include the risk of undergoing a prostate biopsy, particularly infection, and the risk of undergoing treatment for prostate cancer when treatment was not necessary.

In general, it takes 10 to 15 years to achieve maximum benefit after undergoing treatment for prostate cancer. This is because a typical prostate cancer is relatively slow growing and problems, including death, often develop after 10 years. In other words, it does not make sense to undergo screening and treatment of prostate cancer if other medical conditions are likely to shorten your life. For example, if you are a former or active smoker, and are admitted to the hospital multiple times yearly with exacerbation of your COPD/emphysema, it is likely that your lung condition, and not prostate cancer, will be your life limiting disease. Prostate cancer screening in this scenario is unlikely to be beneficial. The life expectancy of an American man is 76 years. Many authorities believe that older men should not undergo screening as they are unlikely to derive benefit.

That said, regardless of age, if you are predicted to live at least 10 years, screening may be right for you. If you are found to have prostate cancer, your treatment options will be based on the risk category of the tumor. This will be discussed in greater detail in next week’s blog. Even if you are found to have prostate cancer that is advanced and/or has spread, treatment can prolong the length and quality of your life.

Again, this is not an easy topic. We at Arizona State Urological Institute would be happy to discuss this in further detail, addressing the particulars of your situation.

Please call (480) 394-0200 to schedule an appointment.

Part 1 – Prostate Cancer: What Options Are Available For Treating Prostate Cancer?

If you are diagnosed with prostate cancer, there are multiple factors which determine your treatment options. These include your PSA level, whether or not abnormalities are felt on your prostate, the amount of prostate cancer present in your biopsy, and the Gleason score, which is a measure of the aggressiveness of the prostate cancer. Multiple scoring systems have been created, using these variables, to determine your prostate cancer risk category. Your risk category determines which treatments are best for you.

For men that have low risk prostate cancer, many advocate for the strategy of active surveillance. This involves undergoing a PSA test and prostate examination every 3 months. Also, to confirm the original biopsy findings, the prostate biopsy is repeated, typically at one year. The idea is that as long as the prostate cancer is stable, there is no need for treatment. Remember that the majority of men with prostate cancer will die with it, not from it. Only if the prostate cancer becomes more aggressive does one proceed to curative therapy. For this strategy to succeed, a man needs to be comfortable not undergoing immediate treatment and be diligent about making all of his appointments.

Men harboring intermediate risk prostate cancer are recommended to undergo treatment with intent to cure. Options include surgical prostate removal, known as prostatectomy, or destruction of the cancer by radiation therapy. In general, it is believed that the chance of cure using either radiation or surgery is equivalent.

Prostatectomy requires a hospital stay and has all of the risks of undergoing major surgery. The advantage of prostatectomy is that the prostate is thoroughly evaluated after removal to determine if the cancer has migrated into the surrounding areas. In addition, way stations for cancers, called lymph nodes, are also removed at the time of surgery, providing additional information regarding whether or not the cancer may have spread. The side effects specific to prostate cancer surgery include urinary incontinence and trouble with erections. A majority of prostates removed in this country are now done using minimally invasive techniques, with the aid of a robot.

Radiation therapy for prostate cancer can occur with the entire radiation dose given at once, called brachy- or seed therapy, or the radiation dose given in small amounts during the course of many weeks, called IMRT. For more advanced prostate cancer, both IMRT and brachytherapy are sometimes combined. While avoiding major surgery, problems with urination and erections can still occur, in addition to irritation of the rectum and bladder, leading to urinary and fecal urgency, bleeding, and discomfort.

As with everything having to do with prostate cancer, there is no straight-forward answer. We at Arizona State Urological Institute would be happy to discuss these issues with you in further detail.

Please call to schedule an appointment at (480) 394-0200.

BPH (Benign Prostatic Hyperplasia)

The physicians of ASUI have been treating men that are suffering from symptoms associated with Benign Prostatic Hyperplasia, or BPH. with the UroLift® System, a proven, minimally invasive technology, since 2016.

The physicians state that: “The UroLift System preserves sexual function which is important to men and their partners. Patients like, that they can have the treatment done in the office, in under an hour, with local anesthesia. And best of all, they experience rapid symptom relief and return to normal routines quickly,”

Nearly 40 million men in the United States are affected by BPH. Not to be confused with prostate cancer, BPH occurs when the prostate gland that surrounds the male urethra becomes enlarged with advancing age and begins to obstruct the urinary system. Symptoms of BPH often include interrupted sleep and urinary problems, and can cause loss of productivity, depression and decreased quality of life. 

Five-year data from a randomized study shows the UroLift System offers not only rapid improvement, but also durable relief for patients with BPH. After five years, patients treated with the UroLift System continue to experience symptom relief with minimal side effects, with few patients requiring additional treatment for relief. A second randomized clinical trial called BPH6 demonstrated that the minimally invasive UroLift System compares very well to the reference standard surgery, transurethral resection of the prostate (TURP), with regard to efficacy, and is superior to TURP at preserving sexual function and offering a more rapid recovery. 

Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of medication treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative is surgery that cuts, heats or removes prostate tissue to open the blocked urethra. While current surgical options can be very effective in relieving symptoms, they can also leave patients with permanent side effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation.

To schedule a consultation with the physicians of ASUI, please call Arizona State Urological Institute at (480) 394-0200.

Free Kidney Stone Seminar in April 2014

Don’t get rocked by kidney stones. Come hear one of our urologists, Dr Karlovsky, give a 1 hr free seminar on what causes kidney stones and what can be done to prevent them. The talk will be held on Wednesday April 23, 2014, 5:30pm-6:30pm.

Mercy Gilbert Medical Office Building
McAuley Conference Room B

3420 South Mercy Road
Gilbert, AZ 85297

RSVP to ResourceLink at (480) 7285414 Space is limited so call and reserve a spot now. Refreshments and free literature on stone prevention will be available.

Mesh and the FDA Regulatory Process

The FDA is perceived and promoted as the guardian of public safety, but many are critical of the FDA approval and regulatory process for being either slow or broken. Some groups see the FDA as being too slow to approve new drugs or treatments that can extend for save lives, while others see the FDA as being reckless and approving drugs and devices that then get recalled after complaints or complications become known.

When it comes to mesh used for vaginal prolapse and incontinence surgery, there is a lack of knowledge about the FDA and the approval process and the necessary requirements that must be met prior to FDA allowing a manufacturer’s device to come to market. Currently there are approximately 100 mesh kits or devices approved/cleared by the FDA to be used in vaginal surgery. Here is a brief synopsis.

Stemming from the 1970’s the FDA passed regulations related to the classification and safety of surgical devices that we still use today with little updating. The FDA’s Center for Devices and Radiological Health (CDRH) is vested with the responsibility of ensuring the safety and effectiveness of ALL medical devices marketed in the US. The Food Drug and Cosmetic Act outlines devices to be classified into three categories based on the risk it poses to the human body:

Class I Device: Low risk device, where clinical data is not needed for approval, but general manufacturing controls are needed. An example of this is simple surgical instruments

Class II Device: Intermediate risk device. Surgical mesh falls into this category, and it requires “special controls” and labeling, but clinical trials are not absolutely required prior to marketing. A device can be approved if it is “substantially equivalent” to a prior device that is used for the same purpose. Vaginal mesh was deemed “substantially equivalent” to prior approved hernia mesh. This is known as the 510(k) Pre-Market Notification Process. It is used a s “piggyback process” to bring devices to market without strict human trials.

Class III Device: Complex/High risk. (3-5% of all products.) Requires stringent Pre-Market Approval, known as the 522 Process, requires strict manufacturing inspections, trials, post-Approval study of data, annual reporting to the FDA. An example of this is hemostatic agents (surgical foam that prevents bleeding).

The FDA is currently forcing manufacturers to conduct “522 studies” on their mesh products for vaginal surgery to evaluate prolapse surgery done with and without mesh. There are more than a hundred studies reporting outcomes of mesh, and except for a few, there are lacking large comparative trials which are now underway. For the standard mesh slings (TVT or TVT-O, and similar slings), the FDA is not requiring these studies as ample outcome and safety data exist. Depending on the outcome of the prolapse mesh studies, mesh may or may not be reclassified as a Class III. This does not mean that mesh is off the market or cannot be used in the meantime. Mesh complications can and should be reported to the FDA, but exact percentage of complications from mesh is difficult to know because mesh complications are underreported and the total number of mesh cases are not known.

Kidney cancer linked to the herb “Aristolochia” aka Birthwort

Using genomic sequencing, researchers have confirmed a link between a plant compound contained in common herbal remedies and upper urinary tract cancer.

For their study, genomic sequencing experts at Johns Hopkins University, Baltimore partnered with pharmacologists at Stony Brook University, Stony Brook, NY to reveal a striking mutational signature of upper urinary tract cancers caused by aristolochic acid, a plant compound contained in herbal remedies used to treat a variety of ailments such as arthritis, gout, and inflammation.

Aristolochic acid is found in the plant family “Aristolochia,” a vine known widely as birthwort, and while the FDA first warned of its cancer-causing potential in 2001, botanical products and herbal remedies containing it can still be purchased online. Moreover, the vine has been found to be an environmental carcinogen through the contamination of food supplies of farming villages in the Balkans, where Aristolochia grows wildly in the local wheat fields.

For years, scientists have known of some mutations in upper urinary tract cancer patients exposed to the plant toxin. But the genome-wide spectrum of mutations associated with aristolochic acid exposure remained largely unknown.

For the current study, which was published in Science Translational Medicine (2013; 5:197ra102), the authors used whole-exome sequencing on 19 Taiwanese upper urinary tract cancer patients exposed to aristolochic acid and seven patients with no suspected exposure to the toxin.

“Genome-wide sequencing has allowed us to tie aristolochic acid exposure directly to an individual getting cancer,” said co-author Kenneth Kinzler, PhD, of the Johns Hopkins Kimmel Cancer Center. “The technology gives us the recognizable mutational signature to say with certainty that a specific toxin is responsible for causing a specific cancer. Our hope is that using the more targeted whole-exome-sequencing process will provide the necessary data to guide public health decisions related to cancer prevention.”

Specifically, Dr. Kinzler and colleagues said they found an average of 753 mutations in each tumor from the toxin-exposed group compared with 91 in tumors from the non-exposed group. This level of mutation is more than that found in melanomas caused by ultraviolet radiation and lung cancer caused by smoking.

Members of the toxin-exposed group had a large number of a particular, rare type of mutational signature in the ATCG chemical code of their DNA. The predominant mutation type in the toxin-exposed tumors (72%) was an A substituted with a T. In one instance, the scientists used the mutational signature to uncover an artistolochic-related tumor in a patient who was unaware of prior exposure.