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Keith Loria is a contributing writer to Medical Economics.
Prostate cancer is often “indolent,” so it can be monitored and not treated right away.
The usual approach to cancer treatment is to act fast and use some combination of surgery (if it is a solid, operable tumor), radiation and chemotherapy to get rid of as much of the cancer as possible.
But for many men with localized, low-grade prostate cancer, the best course seems to be active surveillance: closely monitoring the disease and putting off treatment until the cancer progresses. Active surveillance for prostate cancer is firmly in the mainstream of cancer treatment. The National Comprehensive Cancer Network (NCCN) and other groups have guidelines that say it is the preferred option for many men with localized, low-grade prostate cancer. Research reported last year in JAMA showed that the proportion of men with localized, low-grade prostate cancer who chose active surveillance or watchful waiting increased from 14.5% in 2010 to 42% in 2015. Watchful waiting is now commonly understood to mean monitoring the cancer but with no intention to treat it because of the patient’s age or poor health.
Active surveillance is commonly used to manage prostate cancer, because localized prostate cancer is often slow growing, is unlikely to metastasize and doesn’t cause symptoms. But physicians and patients take the same approach with some other similarly “indolent” cancers. The American Thyroid Association guidelines, for example, recommend active surveillance as an option for people with low-risk papillary thyroid cancer. Sometimes active surveillance is a strategy used after initial treatment — for example, it’s an option for men with early-stage testicular cancer who have had orchiectomy (surgery to remove one or both testicles).
As accepted as active surveillance has become, it still involves many gray areas and judgment calls. Is it an option for men whose prostate cancer is in the intermediate-risk category? The particulars of germline gene testing — which men should get it and which genes should be tested for — are still being hashed out. Research has shown that mutations in the BRCA1 and BRCA2 genes, plus a few others, are associated with aggressive, possibly lethal prostate cancer. The NCCN guidelines recommend germline testing for men with low- and intermediate-risk prostate cancer if they have a family history of inherited cancer or certain histologic findings. There is also the question of what exactly active surveillance should entail. Until fairly recently, men underwent invasive biopsies if rising PSA levels or abnormalities detected with a digital rectal exam suggested that their prostate cancer might be growing. Now it is an open question whether an MRI imaging, at least in some situations, might replace biopsies as a way of detecting the disease.
Regardless of the updates, active surveillance is fundamentally a wait-and-see approach to cancer. “It is a way of monitoring prostate cancer that isn’t causing any symptoms or problems,” says Ronald Tutrone Jr., M.D., FACS, of Chesapeake Urology in Baltimore.
Active surveillance of prostate cancer emerged as a strategy partly because widespread screening for the disease with PSA tests resulted in many more early cases being discovered. The U. S. Preventive Services Task Force and other groups have adjusted their screening recommendations, but there is still plenty of screening and early detection occurring.
“We find the cancer when it’s early and low risk,” notes Dan Sperling, M.D., DABR, medical director and founder of the Sperling Prostate Center in Florida and New York. The average age of diagnosis is dropping, and “younger men with low-risk prostate cancer do not want to risk the urinary and sexual side effects of whole-gland treatments like surgery and radiation,” adds Sperling. His center’s website says that Sperling specializes in MRI imaging and that he has developed a special technique called BlueLaser 3T mpMRI.
Sperling points to research results published in the July issue of the Journal of Urology as evidence for the wisdom of active surveillance. The study included 2,664 men who were managed with active surveillance at Memorial Sloan Kettering Cancer Center in New York City. The treatment-free probability at 5, 10 and 15 years was 76%, 64% and 58%, respectively, and the risk of distant metastasis was 0.6% at 10 years.
Men often improve their health habits after a prostate cancer diagnosis in hopes of lowering the risk of the cancer growing and metastasizing. There is no guarantee, of course, that the changes will affect the course of their cancer, but the men who make them wind up looking and feeling better, according to Sperling: “Some men on active surveillance say that getting a prostate cancer diagnosis was one of the best things that could have happened.”
Nitesh Paryani, M.D., founder and medical director of Tampa Oncology and Proton, says that over the last decade, oncologists have learned that perhaps not all prostate cancer patients require treatment and that active surveillance can spare some men from the risk of treatment side effects, which include erectile dysfunction and urinary problems. But as Paryani notes, active surveillance is not without its risks. Repeat biopsies can also lead to erectile dysfunction and other problems. “Many patients opt not to pursue active surveillance due to this,” says Paryani, adding that the “anxiety of having a cancer diagnosis often plays a role as well.”
Ardeshir Rastinehad, D.O., vice chair of urology at Lenox Hill Hospital in New York City and director of prostate cancer at the Northwell Health, a New York metro area health system, says that “watchful waiting” is more accepted today because of biomarkers, MRI scans and “fusion biopsies” that allow clinicians to use MRI scans to guide biopsies: “Imaging, biomarkers and genomics are helping us pick the right patients that need treatment and the others that we can follow and, hopefully, will never be affected by prostate cancer and can avoid the effects of treatment,” says Rastinehead.
Advances in testing
Tutrone of Chesapeake Urology recently treated Baseball Hall of Famer Cal Ripken Jr., who received a diagnosis of prostate cancer earlier this year (Ripken was treated surgically and has told reporters the treatment was successful). Tutrone recommended a liquid biopsy test called the ExoDx Prostate Test. The developers of the urine-based test, which measures exosomal RNA associated with the presence of prostate cancer, say that it is a better indicator of prostate cancer risk than the conventional PSA test and therefore might help some men avoid unnecessary biopsies.
A study published in May 2020 showed that the ExoDx Prostate Test can influence clinician and patient behavior. Conducted in collaboration with CareFirst Blue Cross Blue Shield, a Blues plan in the Maryland; Washington, D.C.,; and Northern Virginia market, this study included more than 1,000 patients and about 70 urologists. When the results of the ExoDx Prostate Test were used and evaluated in a clinical setting, 92% of patients followed the physician’s recommendation to defer having a prostate biopsy. “Payers really like it when patients follow physician recommendations,” Tutrone says. “And early detection of prostate cancer is key to saving lives and reducing costs over time.” The test was also associated with the discovery of more high-grade prostate cancers.
Rastinehad at Lenox Hill Hospital says that a “middle way” between active surveillance and treatment, called focal therapy, is being studied. Focal therapy zeroes in on small tumors in the prostate but leaves the rest of the gland intact. “In patients that are not great candidates for active surveillance but have disease we can see on MRI, we may be able to treat just the abnormal spot and keep men from having those unwanted side effects of surgery and radiation while still trying to achieve cancer control,” he says.
Keith Loria, a regular contributor to Managed Healthcare Executive®, is a freelance writer in the Washington, D.C., area.