I resigned myself to surgery, and went to see Daniel Eun, MD, a urologic oncologist and robotic surgeon at Temple University in Philadelphia. Trained at Detroit’s Vattikuti Urology Institute that pioneered robotic prostate surgery, Dr. Eun upended my expectations. He essentially talked me out of giving him my business.
Dr. Eun told me I may be a good candidate for a protocol called active surveillance. Instead of surgery, I’m enrolled in a program that involves a regimen of PSA tests and prostate biopsies over time. I can opt for surgery at any time, or, if my cancer never progresses or invades the lymph nodes, avoid it altogether. The program I’m in includes an initial ultrasound-MRI fusion imaging of the prostate at Fox Chase Cancer Center in Philadelphia.
Courtesy Temple University Health System
How it works
About 220,800 new cases of prostate cancer are diagnosed and about 27,500 men die from the disease in the United States each year (see chart). For more aggressive forms of prostate cancer, prostatectomy or radiation are the best courses. For men with very low-risk or low-risk prostate cancers, surgery and radiation are good options and typically have excellent outcomes, but most types of prostate cancer progress slowly, and increasingly men with prostate cancer in those categories are choosing to avoid or delay surgery.
Two alternatives to surgery or radiation exist: watchful waiting and active surveillance. Watchful waiting is less intense and is mainly for men who are older or sicker and likely to die of something else besides prostate cancer. With watchful waiting, if a patient needs treatment, the goal is usually palliative rather than curative, according to Marc Dall’Era, MD, a University of California–Davis urologic oncologist. If the cancer becomes symptomatic, the typical treatment is hormonal therapy rather than surgery or radiation.
Active surveillance, on the other hand, involves what the name suggests: “actively monitoring favorable-risk prostate cancer and offering selective curative treatment when necessary due to signs of disease progression,” says Stacy Loeb, MD, an assistant professor of urology and population health at New York University School of Medicine and a National Cancer Institute grant recipient to study active surveillance in prostate cancer.
Active surveillance isn’t for every man with prostate cancer. It’s appropriate for men with prostate cancer classified as being low risk or very low risk. Prostate cancer risk is based on several factors: PSA, estimated volume of cancer, the stage (physically how far the cancer has advanced) and the grade (how aggressive the cancer looks under a microscope). The Gleason grading system assigns a score of 1 to 5 to indicate the aggressiveness of the cancer, with 5 being the worst. The Gleason score is a composite of the two most prevalent cancer cell types that the pathologist can identify from the biopsy samples. The first number is the most prevalent cell type and the second number is the second most prevalent. A total Gleason score of 6 (3 for primary grade and 3 for secondary grade) is considered low risk, typically with an excellent prognosis. If the estimated volume of cancer is low, the patient may be a good candidate for active surveillance.
A Gleason score of 7 (3 for primary grade, 4 for secondary grade) is considered a low to intermediate risk (depending on estimated cancer volume) and acceptable for some active surveillance protocols. However, a score of 7 based on a primary grade of 4 and a secondary grade of 3 is considered an intermediate risk, and usually is recommended for treatment. Any PSA above 20 ng/mL or a total Gleason score of 8 or greater is considered high risk and a marker for treatment. (My total Gleason score is 6.)
More men are choosing active surveillance. A study presented at the American Urology Association meeting in May showed a roughly 50–50 split between active surveillance and surgery among men seen at eight large urology practices. About 70% of those with very low-grade cancer picked active surveillance.
Because prostate cancer grows slowly, particularly in older men, research has shown that men on active surveillance typically avoid treatment for prostate cancer for years — and many avoid it altogether. A Johns Hopkins study published last month in the Journal of Clinical Oncology found that men on active surveillance stayed free of intervention an average of 6.5 years after diagnosis, and that about 40% hadn’t had surgery at 10 years
A number of studies have reported that active surveillance for low-risk prostate cancer can reduce health care costs compared with surgery and other interventions. A study in the January 2015 issue of the Journal of the National Comprehensive Cancer Network reported that over a five-year period, treatment costs $18,827 more per case than observation, which in this study was defined as including both active surveillance and watchful waiting. These researchers estimated that enrolling 80% of the men with low-grade disease who will never die of prostate cancer in an observation program would save $1.32 billion per year nationally.
Dall’Era at UC Davis reported in Current Opinion in Urology in May 2013 that active surveillance can result in a net per-patient savings of $12,194 at five years and $4,329 at 10 years compared with immediate treatment based on Medicare reimbursement rates for Northern California. Those amounts are an average, and Dall’Era notes that the most expensive scenario is a man who is on active surveillance for several years and then winds up getting treatment.
The economics of active surveillance look even better if men get more expensive radiation treatments or proton beam therapy, which can be priced at up to $50,000 per treatment course compared with about $15,000 for surgery. In a group health model, the savings accrue because of the sheer volume of men who avoid intervention. “If you look over time, the majority of men, anywhere from 50% to 70% of the group, will not require any prostate cancer treatment,” Dall’Era says.
A Canadian study also found that active surveillance saves money. Published in the Canadian Medical Association Journal Open in April 2014, the study showed the average cost of a man on active surveillance through five years was $6,200 (amounts in Canadian currency) compared with $13,735 for initial treatment. For individual patients who were in active surveillance and then had surgery or radiation, the average cost was $16,257.
As in Dall’Era’s research, the economic benefit came when men avoided surgery, says study author Alice Dragomir, PhD, of McGill University in Montreal. “In fact, only about 25% of patients cost more if they receive immediate treatment; however, 75% of the initial patients on active surveillance will remain on active surveillance, which means they cost less than $3,000 for the same period,” she says. Her study estimates the overall savings to the Canadian health system at around $100 million annually for each cohort of men newly diagnosed with prostate cancer.
Even with these documented economic benefits, health plans are reluctant to insert themselves into the conversation about which course is best for individual patients. Several contacted for this article declined to comment. Don Liss, MD, vice president of clinical programs and policy for Independence Blue Cross in Philadelphia, says his company stays neutral because of the debate. Independence Blue Cross believes the best approach for patients is to talk with well-trained, caring physicians who will engage them in shared decision making, he says.
But there are obstacles in the way of more men taking the active surveillance route. For one, there are no recent guidelines in this country for active surveillance. At UC Davis, Dall’Era uses what he calls a “middle ground” approach: a second biopsy three to six months after the first biopsy confirms prostate cancer, typically with MRI guidance, and then a third biopsy a year later. After those three biopsies during the initial 18 months, the man in active surveillance gets a biopsy every two to three years, Dall’Era explains. Johns Hopkins’s protocol calls for annual biopsies. At Sunnybrook Health Sciences Center in Toronto, men are rebiopsied between six months and a year after the biopsy that confirms the prostate cancer diagnosis, and then every three to four years afterward.
Loeb says the lack of consensus contributes to a wide variation in practice patterns across the United States. At the annual American Urological Association (AUA) meeting in May, she reported that in the SEER-Medicare population — although most men receive at least one PSA test a year — the frequency of imaging studies and biopsies declined over time, as did the number of patients adhering to the protocols. “One of the current challenges with active surveillance is that most protocols include repeated prostate biopsy,” Loeb says.
Drawbacks of biopsies
Prostate biopsy carries a 1% to 2% risk of infection, according to Matthew Cooperberg, MD, at the University of California–San Francisco. The traditional biopsy method involves insertion of an ultrasound probe into the rectum to guide a biopsy needle that pierces the wall of the rectum and goes into the prostate, which sits directly in front of the rectal wall. Local anesthetic is used and the patient is awake during the procedure.
The transperineal approach involves inserting the biopsy probe through the perineum, the area between the scrotum and rectum. “Transperineal biopsy minimizes the infection risk but is more invasive and usually requires sedation in the operating room,” Cooperberg says. The American Urological Association says transperineal biopsy may be a better option for men who’ve had negative rectal biopsies but still have other risk factors of prostate cancer, such as family history and a series of consistently high PSA scores. The cost of transperineal biopsies are considerably higher than the transrectal approach. Transperinal biopsies are done in an operating room under general anesthesia while the transrectal can be done in a doctor’s office.
Overall, prostate biopsy is a safe procedure. “Some studies have reported long-term voiding symptoms and/or erectile dysfunction after multiple biopsies, but this literature is pretty inconsistent,” Cooperberg says. “There’s also the theoretical concern that surgery may be more difficult after multiple biopsies, but again, that’s mostly a theoretical concern.”
Reported complication rates after prostate biopsy are all over the place, as a quick review of the medical literature shows. For example, a study published last year in the Korean Journal of Urology found infection rates from transrectal biopsy were between 6% and 8%, but that the 12-core biopsy had lower infection rates than the 6-core approach. But another study published last year reported infection rates about half that. As for noninfectious complications, an analysis by NYU’s Loeb in European Urology in 2013 showed that up to 25% of men have transient lower urinary tract symptoms after biopsy, but fewer than 2% have frank urinary retention, although rates with the transperineal approach were slightly higher. A large 2014 National Cancer Institute study reported infection rates of less than 1% and rates of other complications of slightly higher than 1%. Regardless of how the biopsy numbers shake out, the long-term risk to quality of life or urinary or sexual functioning is much less with biopsies than it is with surgery, notes Dall’Era.
The anxiety over frequent prostate biopsies for men on active surveillance may fade as new tests and less-invasive imaging technologies, such as MRI and genetic testing, emerge and reduce the need for repeat prostate biopsies. “There is significant research into noninvasive ways to monitor patients during active surveillance,” says Loeb.
MRI-ultrasound fusion targeted biopsy can detect high-grade prostate cancer more precisely than traditional methods. Traditional biopsy snatches a small tissue sample and, if it’s cancerous, can tell the density of the cancer cells and its Gleason grade. However, it doesn’t provide any information about the tumor size or shape. That’s where MRI-ultrasound fusion can come in handy.
“For years we struggled with how we really see the cancer, because we can’t see it well on ultrasound, we can’t see it very well on CT scan, and even for a long time we weren’t really sure how well we could see it on MRI,” says Eun, the Temple University surgeon. MRI-ultrasound fusion involves the radiologist pinpointing suspicious areas on the MRI, and then the urologist uses that as an overlay map of sorts on ultrasound to target the biopsy needle to the cancerous tissue.
“If we’re able to do that, then we can dial in that distinct location where the lesion is and then target the biopsy in a much more effective way instead of doing random biopsies,” Eun says. To give you an idea of the costs, the prostate MRI would cost around $6,500 out of pocket without coverage, but the health plan paid around $2,000, based on the explanation of benefits from my own case. A traditional biopsy costs about $1,700 and the pathology report up to $4,000, but my health plan paid a contracted rate of about $1,400 for both.
The advantage of MRI is that it gives a more accurate picture of the size and location of the cancerous cells than a biopsy, which tells only that cancerous cells exist in the sample. That type of imaging technology is limited to major academic and cancer centers today, but when it does become more widely available, it could lead to more precise active surveillance protocols and even more men avoiding, or at least delaying, prostate cancer treatment. Fortunately for me, that MRI technology is within driving distance, and it has given me good news; the lesion is barely noticeable on imaging. I’ll have another transrectal biopsy in December, making it two biopsies and an MRI in my first year of active surveillance.
Well into it
My out-of-pocket costs are considerably lower than what they would be with surgery, which would be my treatment of choice because I don’t have the higher copayments for hospitalization and surgery. Along with PSA testing every three months — again, yielding encouraging results in that the scores have declined some — I’m well into active surveillance, even participating in a clinical trial investigating patient preferences for prostate cancer care. Dr. Eun may yet get my business — I can opt for surgery at any time — but for now I feel like I’m in control of my course of care.
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Paul Lendner ist ein praktizierender Experte im Bereich Gesundheit, Medizin und Fitness. Er schreibt bereits seit über 5 Jahren für das Managed Care Mag. Mit seinen Artikeln, die einen einzigartigen Expertenstatus nachweisen, liefert er unseren Lesern nicht nur Mehrwert, sondern auch Hilfestellung bei ihren Problemen.