While up to half of prostate cancer cases are not life threatening, most patients choose to treat the disease with surgery or radiation. A new web-based program aims to help reduce unnecessary treatment.
In recent years, doctors have recognized that there has been overdiagnosis and overtreatment of men with prostate cancer. While prostate cancer is the most common cancer among men other than skin cancer, it is often low risk and most men won’t die from the disease.
In October, the National Proactive Surveillance Network (NPSN) was launched by the Prostate Cancer Foundation (PCF), Johns Hopkins Medicine and Cedars-Sinai Medical Center to provide an online system for men to better track the status of their early-stage cancer.
The organization also plans to educate men about active surveillance so they can avoid getting unnecessary surgery and/or radiation.
Keeping a Watchful Eye
Active surveillance is a more intensive form of “watchful waiting.” According to the American Cancer Society (ACS), active surveillance means monitoring early-stage cancer closely with prostate-specific antigen (PSA) blood tests, digital rectal exams (DREs), and ultrasounds at regular intervals to see if the cancer is growing.
A PSA test measures the level of prostate-specific antigen in the blood. The higher the level, the greater the possibility for prostate cancer.
Prostate biopsies may also be performed to assess the likelihood that the cancer may grow, according to the National Cancer Institute. Doctors often use a Gleason score to rate how different the tumor tissues looks compared to normal tissue, and how likely the cancer will grow or spread. Most men with early-stage prostate cancer have a Gleason score of 6 or 7 (out of a range from 2 to 10). Through this regular monitoring, doctors can respond promptly with the proper treatment if the cancer should progress.
Watchful waiting, according the ACS, describes a less intensive type of follow-up with fewer tests. It relies more on changes in a man's symptoms to decide if treatment is needed.
Dr. Stuart Holden, medical director of The Prostate Cancer Foundation and director of the Louis Warschaw Prostate Cancer Center at Cedars-Sinai in Los Angeles, told dailyRx News that the Network calls its approach “proactive surveillance” because it is trying to anticipate and solve future problems.
The National Proactive Surveillance Network is gathering comprehensive data on a large number of prostate patients, storing all tissues that are removed from participating patients and studying them to help make better diagnoses in the future.
“We’re storing the biopsy specimens, the blood specimens and urine specimens in a bio repository,” said Dr. Holden. “These tissues will be the subjects of scientific interrogation. In other words, suppose we have patients who meet the criteria for good-prognosis cancer. Yet in the next year or two, they develop a more aggressive cancer. We can go back and look at the tissues, urine and blood specimens to determine if there is a biomarker or some other chemical or molecular target that predicts in advance whether the cancer will behave in a more aggressive way down the road.”
Dr. Holden says if they can find better biomarkers that will predict if a cancer will be more aggressive, patients will not need active surveillance. “We will be able to diagnose people with cancer and either relegate them to a group of people who do need treatment or a group of people who don’t need treatment,” he said. “The goal is to be able to pick out the patients who would really benefit the most from treatment and ultimately reduce the death rate from prostate cancer.”
Controversy Over PSA Testing
Currently, the National Institutes of Health says that candidates for surveillance are men who have a Gleason score of 6 or less and a PSA level less than 10. These two factors taken together have been indicators that cancer a patient has may be at an early stage.
For years, many doctors and professional organizations have encouraged yearly PSA screening for men beginning at age 50, according to the National Cancer Institute. PSA levels have been a standard part of active surveillance.
Now, however, some doctors are questioning the value of PSA screening.
Elevated PSA levels are not always a sign of cancer. Levels can rise from a benign enlargement of the normally kiwi-sized prostate (benign prostatic hyperplasia). Also, infections and inflammations of the prostate (prostatitis) can push up PSA readings. PSA levels also naturally increase as a man ages.
Even if PSA testing is identifying cancer correctly, the United States Preventive Services Task Force questioned its value. The organization stirred debate when it issued a controversial recommendation advising against regular prostate cancer screenings for healthy men in the spring of 2012. It concluded that the risks far outweigh the benefits. The American Urologic Association and other organizations, however, maintain the test is of value and will help save lives.
Why would it be bad to take a test that detects cancer? It comes back to the fact that prostate cancer is slow-growing and non-life threatening in up to 50 percent of diagnosed cases, according to the Prostate Cancer Foundation.
“We’re detecting many cancers which probably don’t pose a threat to the man if left undiagnosed and ultimately untreated,” said Dr. Holden.
Once patients receive a high PSA score, however, it is common practice to have a biopsy. Taking these tissue samples can be painful and possibly cause infection and emotional distress. In addition, E. David Crawford, MD, professor of surgery/urology/radiation oncology and Head of Urologic Oncology at the University of Colorado, Denver, told dailyRx News that 75 percent of prostate biopsies find no cancer.
If the presence of cancer is confirmed, the majority of men with early-stage prostate cancer opt for immediate treatment such as surgery or radiation. They often just want the cancer out of their bodies, regardless of whether or not it poses a danger.
“For a lot of patients, the idea of watching and waiting is too anxiety provoking,” said Dr. Holden. “They may get pressure from their spouse or child saying, ‘Gee, dad was diagnosed with cancer and he’s chosen not to do anything about it. Has he lost his mind?’ It’s going to take educating the public and that’s why we’re here.”
The question also arises: Is surgery worth it? Research published in July in The New England Journal of Medicine found that in 731 men with early-stage prostate cancer, on average, who had their prostate surgically removed lived just as long as those who had no treatment at all. About 90 percent of men with early-stage disease choose surgery or radiation, according to Dr. Timothy J. Wilt, lead author of this study and professor of medicine at Minneapolis Veterans Affairs Center for Chronic Disease Outcomes Research.
A Search for New Biomarkers
The growing controversy helped spur the creation of the National Proactive Surveillance Network. Dr. Holden says that by gathering data on a vast number of prostate cancer patients, they hope to find a biomarker that is better than PSA that can distinguish between slow-growing and aggressive cancers.
“There are already new markers out there that will help men determine if they are actually candidates for active surveillance—such as PCA3 [a prostate cancer antigen] and Myriad's Prolaris test [a method to identify prostate cancer patients at high risk of progression by measuring cell cycle progression genes],” said Dr. Crawford.
Dr. Holden hopes collecting of data on thousands of men with early-stage prostate cancer will help find more helpful markers.
How the Network Works
Patients who join the National Proactive Surveillance Network will undergo biannual digital rectum exams (DRE), urine tests and PSA tests, as well as a yearly prostate biopsy. Patients will also answer lifestyle and nutrition questionnaires and record their medical history.
In addition to providing an efficient model for proactive surveillance, the network will collect and sort data in a scientific-blinded fashion—with absolutely no patient name association. Patient samples, including blood and urine, will also be analyzed and banked by Johns Hopkins Medicine on the east coast and Cedars-Sinai Medical Center in the west with patient consent. The repository of blood and urine will support future biomarker and genetic studies.
Currently, the National Proactive Surveillance Network (NPSN) is open to patients, physicians, and researchers at Johns Hopkins Medicine in Baltimore and Cedars-Sinai Medical Center in Los Angeles. Over 1,000 patients are enrolled in the program from Johns Hopkins and several hundred are enrolled from Cedars-Sinai Medical Center.
Dr. Holden says that the plan is to eventually offer the network to doctors and patients around the country, but expansion of the program depends on meeting regulatory hurdles and getting long-term funding.
“If you figure that 220,000 are diagnosed with prostate cancer in the US, I would say that 30 or 40 percent of them might be candidates for this,” said Dr. Holden.
Launched with a $5 million grant from the Prostate Cancer Foundation, the program is free to participants. The Network allows patients to continuously use the online portal to access their data as it accumulates, and review available resources about prostate cancer. Patients can track the progress of treatment, connect with network physicians and receive proactive surveillance alerts. To find out more, visit the NPSN at http://www.npsn.net.