Institutional Review Board Approved Active Surveillance Program in Chicago
NorthShore University HealthSystem is conducting the only Institutional Review Board (IRB) approved active surveillance program for patients in the Chicago area. NorthShore is a comprehensive healthcare delivery system with a wide spectrum of clinical programs that includes four hospitals. NorthShore is also a teaching affiliate for the Pritzker School of Medicine at the University of Chicago. On April 19, 2012 we interviewed Dr. McGuire, Co-Director of the Active Surveillance program. Mike is a graduate of the Pritzker School of Medicine at the University of Chicago (1990). After his residency in urology at Northwestern he completed a fellowship at Memorial Sloan-Kettering Cancer Center Urology. He is now Chief of Urology at NorthShore University HealthSystem and co-director of the John and Carol Walter Center for Urological Health at NorthShore Glenbrook Hospital.
What motivated you to become involved in an active surveillance program?
I’m a fellowship-trained cancer surgeon and I saw too many complications. I am well-trained and I do good procedures. But even so patients still had incontinence and impotence, so I wanted to make sure I actually had to do surgery on the people who really needed it.
What are the goals of the NorthShore active surveillance study?
Our primary research goal is to determine if we can predict which patients with low-grade prostate cancer will have the kind of prostate cancer that will never need treatment. One of our key clinical goals is to help patients avoid the unnecessary side effects of treatment while minimizing risks.
One of the critiques from the NIH Consensus Conference in December, 2011, was that there are too many different protocols for conducting active surveillance. The report suggested a need for one protocol nationwide. What are your thoughts on this?
When we set up our study we wanted to be as conservative as possible so that patients were taking the least risk possible. However, as our study is maturing I am enrolling more and more people who aren’t the so-called “ideal” candidate. Some of the patients are a Gleason 7 (3 + 4) or may start with 3 cores. I believe that we’re learning we’re still overtreating men when using strict criteria.
Though there are many active surveillance protocols at this time, with somewhat different inclusion criteria and monitoring standards, we don’t know which protocol is going to be precisely the best. The only way we’ll know is by doing many studies and following people for 10 to 20 years.
How many cores with cancer meet the inclusion criteria?
Three or less cores is our standard. In our protocol we have what we call the ideal candidate, and something like 90-95% of our patients meet those criteria. But certain men who are under age sixty, certain men who are older or who have a very tiny volume of Gleason 7 disease, they also have the opportunity of being in the study, even if they’re not an ideal candidate.
Our criteria are not absolute. And patient preference is important. If a patient decides he really wants active surveillance and he wants us to monitor him we will do that. Now if a patient has a Gleason 9 cancer and is 45-years-old we will strongly recommend treatment, but it is ultimately the patient’s decision what they do.
In addition, if a patient does not want to participate in our research study, they can still become an active surveillance patient here at NorthShore on an individual basis. I encourage enrollment in the study, though, as I believe the rigorous protocol and surveillance definitely are to the patient’s benefit.
How do you deal with the patient’s fear of the word “cancer” and the anxiety that some men will experience during active surveillance?
In our study we encourage enrollment in our own stress reduction class run by our clinical psychologists. We completed a randomized study of giving patients a book to read on stress reduction versus an actual class requiring active participation. We found that people who took to the class did significantly better at stress reduction, and their cancer quality of life was much improved compared to the other men. We have made this stress reduction class a regular part of our program. It is open to patients and their partners so that both of them can be involved.
How do you address the multiple medical needs of patients?
When a patient is diagnosed with prostate cancer and chooses active surveillance, the patient and his partner often have multiple needs and concerns. We address those needs by providing a spectrum of specialists.
For example, for our active surveillance program we have a pathologist, a radiologist, a medical oncologist, a dietician, a stress reduction psychologist, a specialist in sexual function, and other experts. In addition, we have multiple nurse navigators to coordinate the services. The goal of our integrated patient centered approach is to coordinate services to encompass all aspects of a patient’s needs.
Since we are also a multi-specialty group many options are available to patients. For example, a prostate cancer patient with diabetes can also see one of our endocrinologists.
In addition, we were one of the first hospitals in the country with integrated electronic medical records, so all our physicians see all our records. If you get admitted to the hospital our doctors can access all of the inpatient and outpatient charts, so it’s an excellent way of practicing medicine.
How is on-going education provided to prostate cancer patients?
First, we have nurse navigators who work with patients. In addition, the doctors spend a lot of time educating patients one-to-one. We also have an interest in electronic education so we are involved with the Wiser Care Group from UCLA., a web-based program that helps with patient decision-making. Additionally we also have our psychologist who is also actively involved in cancer related decisions. So, we range from providing one-to-one patient education to providing supplemental information on the web.
What is your take-home message for men considering active surveillance?
Right now I think people are too reluctant to take a small chance with active surveillance. When faced with a diagnosis of cancer, patients reasonably think how they can survive this disease. We as doctors have to get better at predicting which prostate cancer is likely to impact a patient’s life. People underestimate the significance of incontinence and impotence, and all the other problems that go along with having had surgery or radiation.
What’s your view of how urologists are dealing with active surveillance?
Urology is a constantly evolving field. I graduated from residency in 1996 and now most of what I do day-to-day has nothing to do with what I did in my residency. I have hope that urology will keep evolving, and Active Surveillance will become the first-line therapy for many, if not most, men with low-grade prostate cancer.
Ideal Inclusion Criteria
Serum PSA less than < 10 mg/ml and serum PSA must not have increased more than 2 mg/ml in the year prior to diagnoses.
Clinical stage T1C or T2a prostate cancer, verified by a NorthShore University Health System urologist.
Biopsy Gleason Score <6 with no primary or secondary 4 or 5 tumor pattern and pathology, verified by a NorthShore University HealthSystem pathologist.
Diagnosis of prostate cancer made on at least a 12 core needle biopsy with up to 3 cores positive for cancer.
Maximum tumor length <50% of any core.
Total tumor volume <5% of biopsy volume.
No prior treatment for prostate cancer
Test & Measures Schedule
PSA blood test every 6 months
Serum testosterone blood bests every 6 months
Digital rectal exam every 6 months
PCA3 urine gene marker test every 6 months
Confirmatory 12-core biopsy within 6 months after last biopsy with 4 extra cores for research
Repeat biopsies every 2 years using 3-D color Doppler ultrasound
If PSA increases by 0.4 mg/ml on 2 consecutive PSAs or if there is a change in the DRE additional biopsies may be performed.