In addition to the new data from Johns Hopkins, reported earlier this week, that were highly supportive of active surveillance as a first-line management strategy for “favorable-risk” prostate cancer, another recent study has suggested that as many as 67 percent of newly diagnosed patients may be good candidates for such first-line management.
Now The “New” Prostate Cancer InfoLink would like to think that this could be true … but we also believe that this may be stretching the bounds of acceptance at the current point in time. We’re only starting to see a real increase in the acceptance of active surveillance across the urology community and the patient community. It is going to take time before we get truly widespread acceptance of the value of such an approach to management for very large numbers of newly diagnosed men.
However, for what it is worth, here is a summary of what Overholser et al. reported in the Journal of Urology.
The research team set out to estimate what percentage of a population-based cohort of newly diagnosed prostate cancer patients would actually qualify for first-line management on active surveillance. In addition, among those patients who qualified for active surveillance but subsequently received primary treatment by radical prostatectomy, they looked at the proportions of patients who were upgraded or upstaged post-surgery.
To do this, they used data from the 3,828 men enrolled in studies by the San Antonio Center of Biomarkers of Risk for Prostate Cancer (SABOR) — one of the centers involved in the National Cancer Institute’s Early Detection Research Network:
- 320/3,828 men enrolled in SABOR (8.4 percent) had been diagnosed with prostate cancer at the time of this analysis.
- 281 of these 320 men with prostate cancer had provided data sufficent for detailed review and analysis
The research team defined two different sets of criteria to determine suitability for active surveillance as a first-line management strategy:
- Criteria set 1 required patients to have a PSA density of < 0.15 or 15 percent, two or fewer biopsy cores exhibiting cancer, a Gleason score 6 or less, and cancer involving ≤ 50 percent of the total biopsy volume.
- Criteria set 2 required patients to have 4 or fewer biopsy cores exhibiting cancer with a Gleason score of 3 + 3 = 6 and no more than 1 biopsy core exhibiting cancer with a Gleason score of 3 + 4 = 7, with ≤ 15 percent of that core exhibiting Gleason 3 + 4 = 7 disease.
And here is what they found:
- 187/281 patients (67 percent) qualified for active surveillance under criteria set 1 and/or criteria set 2.
- Treatment data were available on 178 patients, of whom 74 underwent radical prostatectomy.
- Of men who met criteria set 1 for active surveillance but underwent radical prostatectomy, 14 (33.1 percent) were upgraded and/or upstaged on pathological review.
- Of men who met criteria set 2 for active surveillance but underwent radical prostatectomy 9 (25.0 percent) were upgraded and/or upstaged on pathological review.
- Of the 94 patients who did not meet either set of criteria for active surveillance but underwent radical prostatectomy, 38 percent were upgraded and/or upstaged on pathological review.
The authors conclude that, in this population-based cohort of > 3,000 patients
… two-thirds of men diagnosed with prostate cancer qualify for active surveillance. Less restricted criteria for surveillance may be appropriate based on similar rates of upgrading/upstaging at radical prostatectomy.
Now it is important to remember, in thinking about these data presented by Overholser et al., that active surveillance is not a first-line management strategy that guarantees that a man will never need treatment for prostate cancer. Rather, it is a first-line management strategy intended to defer treatment with curative intent until it is clear that such treatment is really necessary. By deferring treatment in this way, the patient and the doctor may be able to
- Minimize risk for over-treatment
- Defer risk for such common side effects and complications of treatment as erectile/sexual dysfunction and short- or long-term incontinence
- Defer the impact of curative treatment on quality of life
- Avoid all treatment during the lifetimes of some men who show no indication that treatment is actually necessary
There are always going to be some men who will choose immediate curative treatment as opposed to active surveillance, however well-qualified they are for active surveillance as a first-line management strategy.
Filed under: Diagnosis, Living with Prostate Cancer, Management, Risk, Treatment | Tagged: active, application, criteria, Management, surveillance |
THE "NEW" PROSTATE CANCER INFOLINK 
Note to all those who feel the urge to pontificate about the virtues of “whistling past the graveyard”; your first qualification should be to “get the disease” … it has a mind-clearing way of getting your attention! The tendency towards the deification of all things statistical usually tends to fail to remind us that statistics are relevant to populations, not individuals. … While one will justifiably fret about the prospect of never getting laid again, let me remind you, you are getting ready to experience the “Crap-Shoot With Death”!
Note to all those who feel the urge to pontificate about the virtues of “get it outta me now and damn the torpedoes” because they worry that prostate cancer is going to kill them; please be aware that not only do we now have excellent evidence that most men who are diagnosed with prostate cancer will never die from it … we also have extremely accurate ways to determine who really needs curative treatment and when to give it to them if they are diagnosed early enough and appropriately monitored! The above-mentioned “Crap-Shoot With Death” is not like Russian Roulette, when you really don’t know which chamber holds the live round.
Advantages and Disadvantages of Relaxed Active Surveillance Criteria
Thanks once again for this thought-provoking and interesting article on active surveillance.
I’m trying to sort out the advantages and disadvantages of more restrictive versus less restrictive criteria. On one hand, it seems a clear advantage to give more men the option of AS based on less restrictive criteria, especially when these data indicate that a clear majority do so well. On the other hand, earlier treatment for men at substantially higher risk of needing treatment seems attractive, and for years Dr. Laurence Klotz, arguably the leading expert on AS, has pursued an objective of getting apparently eligible men who actually needed treatment recognized earlier in the AS process.
Neither set of criteria here includes: a direct PSA (though partly addressed with the PSA density criterion of < 0.15 in set 1); PSA velocity; any DRE or other staging (though partly addressed by the number/percentage of positive cores and the maximum extent of cancer in the sample); suspicious symptom information; and imaging. At the extreme end of risk, men with disease manifesting little PSA –- such as Gleason 10 in many cases, small cell disease, and endometrial disease –- could be missed without the usual DRE; on the other hand, the biopsy could well reveal such high-risk disease, no doubt leading to treatment, though such a patient would still be counted as eligible for AS in the study. If I were a patient, my feeling today is that I would want to know those other important pieces of information and would want my doctor to consider at least most of them. Perhaps the PSA level is redundant as an individual criterion if you have a well-based PSA density result, but that density figure must be based on a competent DRE or, better, imaging, and if you have that data and of course the associated PSA, why not use it?
I suppose the downside to added information is that some doctors and patients will apply it in a black and white fashion without considering the whole context and shades of gray, which would tend to eliminate some patients who would do well on AS. Are there other downsides to more information? (I can understand not using advanced imaging due to the cost/benefit ratio, but the other information looks worthwhile to me.)
Another Advantage to Deferring Treatment with Active Surveillance — More Time for Technology to Advance!
The additional advantage is that the time passing while the patient is deferring treatment allows technology and medical practice to improve, leading to more effective treatment, a lower burden of side effects, and even better ways to foster longer deferral of treatment. A good example of the latter, as discussed by Dr. Klotz in published research, is use of a 5-alpha-reductase inhibitor in an investigational setting (see for example, Chiang et al.). Another example, this time investigating nutrients to extend the deferral period, is this paper by Thomas et al. This advantage — gaining time — is particularly salient in my mind. While I was hardly on active surveillance, I was able to use advanced intermittent androgen deprivation therapy to gain well over a decade during which radiation, imaging, and other technologies advanced to the point where they could handle my challenging case.
Dear Jim:
(1) The fact that DREs aren’t mentioned in the criteria doesn’t mean they weren’t done. A DRE is a normal event prior to a biopsy (as opposed to just as a way to establish need for a biopsy).
(2) The value PSA velocity is similarly a function of the decision for whether a biopsy might be necessary in some patients. It is not usually a factor in the decision about whether active surveillance is appropriate if the PSA is under 10 ng/ml.
(3) If the patient actually wished to follow an active surveillance protocol, please bear in mind that almost all respectable active surveillance protocols require a follow-up biopsy within 12 months of diagnosis, and that follow-up biopsy would usually be done, today, under MRI/TRUS fusion biopsy.
I think that you are confusing “potential eligibility” for management under active surveillance with the actual criteria required to demonstrate that a specific patient might or might not be a good candidate.
I guess that it didn’t take your father, and you didn’t see your PSA go from 2 to > 10 in 6 months and you didn’t have to suck up a butt-full of radiation to kill it off and you’re not continually waiting for a possible recurrence … right?
My point, dear Natron, has nothing to do with my personal circumstances (or yours) … It has to do with the fact that not everyone who gets diagnosed with prostate cancer is sitting in the same boat at all … and so not everyone is faced with the “crap shoot with death” that you are suggesting. In fact, for most men who get diagnosed with prostate cancer today, death from the disease is not a serious probability … but the side effects of treatment can feel like “death” for many men, which means that avoiding unnecessary over-treatment of clinically insignificant disease is just as important as getting necessary treatment for clinically significant disease.
Hi Natron,
I’m hoping we can enlist your passion about prostate cancer to persuade men to get screened, after they understand that active surveillance is often the best choice if they get diagnosed with a low-risk case, rather than you current apparent view that all men should be treated. As one highly respected medical oncologist has stated, the seriousness of prostate cancer ranges from about as serious as a case of dandruff to as serious as an aggressive case of pancreatic cancer; fortunately, for the vast majority of patients, it is slow growing. Please read about the highly encouraging results for active surveillance in the Johns Hopkins and Toronto (Klotz) long-running series. (Dr. Klotz enrolled the first patient in his series in 1995, nearly 20 years ago.)
Also, thinking here that if your radiation oncologist gave you a butt full of radiation, his aim was really poor and the dose would not have done you much good.
LOL Thanks for the chuckle!
Dear Sitemaster,
I’m responding to your comment to me of September 3, 2015 at 4:19 pm, for which, thanks.
I’m quite aware that I may have missed an important development in active surveillance technology, which has been advancing at an impressive pace — hard to keep up, and again thanks for your help, specifically that the desirability of a DRE and PSA velocity calculation (PSAV) may have been dropped from the AS criteria lists as research has accumulated, especially for a patient with a PSA < 10, the situation you address.
I was basing my comment mainly on the criteria of the 2007 consensus statement from the conference of a large number of active surveillance experts invited by renowned urologist Peter Carroll of UCSF. That list of six criteria, as reported in the Scholz/Blum book "Invasion of the Prostate Snatchers," included "PSA velocity" (<2, meaning an increase of less than 2 ng/ml in the previous year, for low risk — suitable for active surveillance) and digital rectal exam (DRE, with a finding of "no nodule" indicating suitability for active surveillance). (The other criteria included Gleason score, percentage of biopsy cores with cancer, PSA level, and PSA density.) The criteria were aimed at determining which men could "safely" undergo active surveillance, with the term "safely" connoting eligibility to me rather than likelihood of long-term success. The year 2007 is obviously eight years ago, which is a long time in prostate cancer technology advancement. Can you clarify whether these "requirements" have been informally or formally dropped and provide some links?
Thanks for distinguishing between "potential eligibility" and "good candidate." I can appreciate that distinction based on my own case regarding androgen deprivation therapy, as I was "eligible" for androgen deprivation therapy but was not a "good candidate" for long-term success, which I somehow achieved despite the odds.
Dear Jim:
See this report on a recent paper by Dr. Klotz and listen to his recent discussion of AS on CureTalk.