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New Medical Advances: Prostate Cancer

By PAMELA DITTMER MCKUEN
Jay Cohen, MD, had a choice: Endure surgery for his prostate cancer, which he was warned, would cause impotence and incontinence, or die a slow, painful death. Either thought was terrifying. After several breath-taking minutes, he told the surgeon: “Let’s do it.” ...Then fate stepped in. The prostate surgical schedule was backed up for three months. That gave Dr. Cohen, whose specialties are psychiatry and psychopharmacology—not urology—time to breathe. And to learn everything he could about the disease.
   
His initial findings said more about what he didn’t know than about what he did.
   
For example: His repeat tests for prostate specific antigen (PSA), a protein that may signal cancer, were high, and a biopsy showed low-grade cancer on the right side of his prostate gland. But was that the only location? Biopsies frequently miss cancer. Prostatectomy is not recommended for men whose cancer has spread. If he had the surgery, and the cancer had metastasized, the surgery and its side effects were unnecessary.
   
He was 66 and single, and he needed more details.
   
Dr. Cohen, a professor in the Department of Preventive Medicine at the University of California, San Diego, spent a year investigating what he calls “21st Century technologies.” He researched traditional and leading-edge diagnostics and treatments as well as the pioneering practitioners and medical centers. He also steered his own case. When his urologist said magnetic resonance imaging (MRI) wouldn’t be helpful because the prostate is too deeply embedded within the pelvis, Dr. Cohen found an advanced prostate-specific technique and paid for it himself. Then he underwent a color Doppler ultrasound for further confirmation.
   
The results: His cancer was small and located in a relatively safe area. There was a 98 percent chance the cancer would never become bothersome. His treatment direction changed from certain surgery to highly-focused active surveillance, a process of regular, frequent testing.
   
“Get all the data you can, see what it adds up to, and then talk about treatment choices,” he said.
   
Dr. Cohen, who was diagnosed in December 2011, today hopes he is among the 70 percent of men in active surveillance who never need further treatment. In case he does, he is keeping a watchful eye on new studies and new advances. He shares his experience, research and professional contacts in a new book, Prostate Cancer Breakthroughs: New Tests, New Treatments, Better Options (Oceansong Publishing, 2013).
   
“So far, I’ve had a good ending,” said Dr. Cohen. “But it was an intense year and a half.”
  
Prostate cancer is the most common cancer in men. About 240,000 new cases will be diagnosed this year, and about 30,000 will die from the disease, according to the American Cancer Society. The numbers are terrifying, but not all of these cancers are deadly. Most men will die from other causes. As Dr. Cohen found, a major challenge for medical practitioners is accurately differentiating between the dangerous cases 
that require drastic interventions and those that are not life-threaten-ing. The long-held model has been conservative and, in many cases, led to more treatment than necessary.
   
That’s all changing. Prostate cancer is a very active area of medical research. New tests and treatments have been developed, and more are on the way. Studies are being conducted in the fields of genetics, early detection, prevention, surgical techniques and more. Personalized medicine is the ultimate goal, so that patients are treated exactly as they need to be treated, and no more.

Here are some of the latest initiatives:

FEWER FALSE-NEGATIVES  
Each year more than 1 million biopsies are performed in this country. The way the procedure has traditionally been performed, for nearly a quarter-century, is basically blind. Clinicians use a needle to remove 10 to 14 samples from the prostate in hopes of finding whatever cancer might lie. But those samples represent less than 1 percent of the gland, leaving many men open to false-negative conclusions or arduous re-biopsies.
   
ConfirmMDx is a new molecular diagnostic test that helps urologists differentiate prostate cancer-free men from those who may be harboring cancer. Using existing biopsy tissue, the test detects an epigenetic field effect or “halo” that surrounds cancer lesions and, thus, widening the margin for error. MDxHealth, based in Irvine, Calif., and Liege, Belgium, developed the test.
   
“If the patient has a negative biopsy and ConfirmMDx is negative, the likelihood of having cancer is very low,” said urologist Allen Chernoff, MD, who has incorporated ConfirmMDx in his practice at Metro Chicago Surgical Oncology in Wilmette, Ill. “Therefore, something significant would have to change, such as a high PSA, for us to re-biopsy.”
If the test comes back positive, the next step is another biopsy, he said.
   
“Biopsies can be expensive and painful,” he said. “We give a local anaesthetic, but it’s still uncomfortable. 
anaesthetic, but it’s still uncomfortable. There also is the stress of undergoing the biopsy and waiting for the pathology. We can now save some of our patients from going through that.”
 
MRI-CT TARGETED BIOPSY
Prostate cancers are difficult to image with CT technology because of the limited contrast between normal and malignant tissues. The view with MRI is improved, but trying to biopsy a patient inside the tubular machine is cumbersome and time-consuming.
   
A team of physicians and engineers at Clark Urology Center at the University of California, Los Angeles, have shown that prostate cancer can be diagnosed using image-guided targeted biopsy: Fusing Magnetic Resonance Imaging with real-time ultrasound. The patient first undergoes MRI to visualize the prostate and any lesions or suspicious areas. That information is fed into an imaging machine, the Artemis, by Eigen in Grass Valley, Calif. The Artemis fuses the MRI pictures with real-time, three-dimensional ultrasound, allowing the urologist to see the suspicious areas during the biopsy and aim directly at them.

MOLECULAR STAGING
A longstanding unmet medical need is differentiating between aggressive and nonaggressive prostate cancer. Abbott is collaborating with Stanford University in developing a molecular diagnostic test that could do just that, by using certain biomarkers which may identify which patients have fast-growing malignancies. The test is in the very early stages of development.
   
“Radical surgery comes with life-altering post-surgical issues,” said Kathryn Becker, global marketing director in Companion Diagnostics for Abbott Molecular in Abbott Park, Ill., and who holds a doctorate degree in biology neuroendocrinology. “It’s a big decision for a family to have the surgery done. Overall, this genetic test can help establish which men may be able to undergo a milder course of treatment without such harsh conditions, especially if they are over 70 or 75.”
 
SHARPER SCANS DURING RADS
Because the prostate is in constant motion, the need for consistent monitoring during radiation treatment is critical. Clarity ® 4D Monitoring software, by Stockholm-based Elekta, offers real-time, continuous visualization of the precise location of the prostate and surrounding tissues, thereby allowing clinicians to deliver therapeutic radiation beams with sub-millimeter accuracy. That capability is especially important when pursuing advanced protocols such as reduced margin hypo-fractionation—which entails treating patients in shorter courses but with longer individual treatments—because radiation exposure to healthy tissue is minimized. The technology works with a facility’s existing CT simulation without the extra cost and overhead of a dedicated MRI. As for the patients, Clarity ® is non-invasive and requires neither extra radiation doses nor implanted markers.

CATHETER-FREE RECOVERY
Robot-assisted prostatectomy is growing increasingly prevalent. Even more recent is the “catheter-free” recovery, which was developed at the Henry Ford Hospital Vattikuti Urology Institute (VUI) in Detroit. Patients traditionally have a penile catheter to drain urine for up to 10 days while the surgical site heals. The catheter frequently causes pain and irritation. The no-catheter technique involves draining urine directly from the bladder via a small tube, much like an IV tube, placed through an incision in the abdomen.
  
“This is a paradigm shift in techniques traditionally used in urologic surgery that allows us to provide the gold standard of care in prostate cancer while eliminating the No. 1 complaint expressed by our patients—discomfort from a penile catheter,” said Nilesh Patil, MD, a VUI-trained urologist who uses the technique with his patients at Cincinnati-based UC Health University Hospital.
 
A DRUG FOR ADVANCED STAGES
About 4 percent of prostate cancer cases spread, or metastasize, beyond the prostate. Most commonly it goes into the bones, often causing fractures and other skeletal events that compromise survival. Metastatic castration-resistant prostate cancer, or mCRPC, is an advanced stage in which the cancer is resistant to surgery or other medical treatments that lower testosterone levels and has spread to the bones, but not to other parts of the body.
    
This spring the Food and Drug Administration granted fast-track approval for a new intravenous radiation injection, Xofigo ®, which has demonstrated improved survival rates and symptom delay for men with mCRPC. Xofigo ®, developed and marketed by Bayer HealthCare in Wayne, NJ, is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. Study results showed men receiving the injections plus best standard of care lived a median of more than three months longer than those who received placebo plus best standard of care.
 
THE PSA CONTROVERSY
Perhaps the biggest controversy is over PSA screening, the first line of defence since its introduction in 1987. The nearly universal recommendation until now called for men age 40 and over to be tested yearly. In May, the American Urological Association revised its guidelines: Routine screening is no longer recommended for men of average risk under age 55 or over age 70. The changes ignite debate between saving lives versus harmful over-reaction and over-treatment.
   
“PSA is like any other tool—it needs to be used properly,” said Dr. Chernoff. “When it is not used properly, it is a bad tool. That doesn’t mean you throw it away. It means you learn to use it better. The more we can say you do or do not have cancer, the better we can discuss where we go from here.”  
 
“The new 21st Century technologies will change everything,” said Dr. Cohen. “As they become routine, it will make sense to do PSAs again.”



Published: September 03, 2013
Issue: Fall 2013 Issue