As we have noted more than once before, a major problem with being managed on active surveillance is (potentially) whether one’s clinical management team really has been trained to conduct active surveillance in a sufficiently active manner.
The problem is exemplified again by a recent paper by Luckenbaugh et al. in the Journal of Urology.
In this study, the authors set out to monitor the frequency of follow-up (PSA testing and prostate biopsies among men being initially managed on active surveillance in the 42 academic and community urology practices comprising the Michigan Urological Surgery Improvement Collaborative (MUSIC). Luckenbaugh et al. were able to use the MUSIC prospective clinical registry to identify and monitor data on all patients in MUSIC practices who been started on active surveillance between January 2012 and September 2013 and who had at least 2 full years of continuous follow-up. They were then able to assess the degree to which practices had been following NCCN guideline recommendations (at least three PSA tests and one surveillance biopsy over such a 2-year period) for the entire MUSIC group as well as for individual practices within the group.
Here is what they found:
- 513 patients were initially managed on active surveillance within the above-mentioned time frame and had at least 2 years of follow-up.
- 431/513 patients (84.0 percent) remained on active surveillance for at least 2 years.
- Of those 431 patients, 132 (30.6 percent) were monitored according to NCCN guidelines (implying that nearly 70 percent were not) across the entire MUSIC group.
- On an individual practice level, the average (median) rate of patient monitoring according to NCCN guidelines was 26.5 percent (range, 10.0 to 67.5 percent).
- Among the patients who were not monitored according to the NCCN guidelines,
- The absence of a follow-up biopsy within 2 years was common.
- The absence of a follow-up biopsy within 2 years was not very different from practice to practice (median rate, 82 percent).
The authors conclude that, across the 42 practices in the MUSIC group,
… there is wide variation in the proportion of men on active surveillance that meet guideline recommendations for follow-up PSA testing and repeat biopsy. These data highlight the need for standardized [active surveillance] pathways that emphasize the role for repeat surveillance biopsies.
Now we need to interpret these results with some caution. There is no really well-defined set of guidelines for how to monitor patients while they are on active surveillance, and there are good reasons to avoid giving men repeat biopsies unless the need for such biopsies is really evident. Also, for example, we have no idea what percentage of these patients in the MUSIC cohort might have been receiving multiparametric MRIs, genetic/genomic tests, etc.
However, it is generally widely accepted practice that every man placed on an active surveillance protocol should receive at least one repeat biopsy within 12 months of his initial diagnostic biopsy and that all such patients should receive at least semi-annual PSA tests (i.e., every 6 months). If patients in the MUSIC consortium weren’t receiving this level of monitoring, then it is clear that they weren’t really on active surveillance at all … and if they weren’t really on active surveillance at all, then they were at risk for early progression that might not get picked up as early as it should have been.
The “New” Prostate Cancer InfoLink is of the opinion that many urology practices are in need of some serious education about the ways to monitor men on active surveillance, certain minimal criteria that can be used to define this means of monitoring, and accurate mechanisms that define the need for repeat biopsies or suggest that repeat biopsies are not necessary in specific patients. There is never going to be a “one size fits all” process for high-quality active surveillance protocols, but it shouldn’t be difficult to outline the basic criteria, distribute that guidance to the membership of the American Urological Association, and build testing on that knowledge into the physician re-accreditation process.
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: active, quality, standards, surveillance |
THE "NEW" PROSTATE CANCER INFOLINK 
I would like to know the facts about the 6-monthly PSA tests for these subjects, and the results and follow-up on these. Surely the cheap and non-invasive PSA tests can be the first line of monitoring. If PSA rises and at some significantly fast rate, then biopsy is surely warranted. If the PSA does not rise or rises insignificantly, is a biopsy warranted? Are exceptions to the reliability of the PSA marker so many?
in 2016, every patient should already know the high quality active surveillance protocols — like Dr. Klotz’ AS cohort at Sunnybrook (Canada) — and insist on it.
Right?
Dear Grover:
The PSA test is an enormously difficult test to interpret with a high level of accuracy because it is not a prostate cancer-specific test. Almost any form of mild prostate disorder can make a man’s PSA level go up for a while, and it can even vary based on time of day. Thus, it offers a guide but not definitive information. Men with low-risk prostate cancer are still, also, at risk for things like acute and chronic prostatitis and benign prostatic hyperplasia (BPH), all of which can also cause a man’s PSA to rise.
If I was personally on active surveillance for risk of progressive prostate cancer, I would make sure I got every PSA test in the same way as one usually gets blood drawn for things like cholesterol levels — early in the morning before any food or fluid other than water. And the tests should be consistently run at the same laboratory.
The other things that I would be doing, if I was an active surveillance patient would include the following:
— Having my biopsy specimens sent for genetic/genomic analysis
— Having annual multiparametric MRI exams
— Getting a MRI/TRUS-guided biopsy within the first year after my initial diagnosis and after a first multiparametric MRI exam
— Getting regular rectal exams (DREs)
— Getting PSA tests every 3 months for the first 18 months after my initial diagnosis to see just how stable the PSA level was
All of this would help to establish the baseline information for my cancer status. At that point, it might then be reasonable to get repeat PSA tests only every 6 months.
The Canadian team run by Laurie Klotz in Toronto now recommends that PSA velocity is really a rather unreliable guide to whether a patient needs a repeat biopsy, and I get the impression that they are relying at least as much on multiparametric MRIs in such patients before deciding whether repeat biopsies are a good idea.
If I was on active surveillance and there was a significant increase in my PSA level from one test to the next, the first thing that I would want to do would be to get that test repeated in a month’s time, to be sure that this sudden increase was “real”. Often PSA levels can rise and then drop back down again.
Walt:
Well, in theory, yes … but that’s like saying everyone who owns a car should know how to maintain it properly by getting it serviced regularly by a competent mechanic (or by servicing it themselves). We know that that doesn’t happen!
This is shocking to me. We recently saw what happened in the ProtecT trial when the “active surveillance” protocol did not include mandatory confirmatory biopsies or follow-up biopsies — there were unacceptable rates of metastases. With about 30% of original TRUS biopsy Gleason scores upgraded at prostatectomy, it can be disastrous to neglect repeat biopsies. I’m sure that they don’t have to be annual for most low-risk or very low-risk men, but there have to be some.
This year ASCO basically endorsed Cancer Care Ontario’s active surveillance protocol. Their guidelines state:
“At least a 12-core confirmatory TRUS guided biopsy (including anterior-directed cores) within 6 to 12 months, and then serial biopsy every 2 to 5 years thereafter or more frequently if clinically warranted. Men with limited life expectancy may transition to watchful waiting and avoid further biopsies.”
With both NCCN and ASCO calling for biopsies on active surveillance, one would think that urologists would be wary of not following the standard of care. Perhaps the AUA ought to issue guidelines as well.