Active Surveillance Key to Limiting PSA-Related Overtreatment, but Remains Difficult Sell

Jason M. Broderick @jasoncology
Published: Friday, May 31, 2013
E. David Crawford, MD

E. David Crawford, MD

Active surveillance for low-grade prostate cancer has long been considered the elusive “holy grail” for mitigating the overtreatment effect of PSA screening. At the 2013 IPCC®, E. David Crawford, MD, provided an overview of active surveillance and discussed a few potential methods for increasing its use.

Patients commonly misinterpret active surveillance as “doing nothing.” In actual clinical practice, “[It] means that you’re going to individualize management, you’re going to follow these patients, and if you need to, you’re going to jump in early with the idea that you’re going to cure them,” explained Crawford, professor of Surgery and Radiation Oncology, and head of the Section of Urologic Oncology at the University of Colorado Denver School of Medicine, as well as associate director of the University of Colorado Comprehensive Cancer Center, also in Denver.

Crawford said that one of the difficulties with convincing patients to choose active surveillance is that treatment is highly effective. A seminal paper by Eggener et al found that in a population of over 12,000 men with low-grade prostate cancer (usually Gleason 6) treated with radical prostatectomy, the 20-year prostate cancer specific mortality was 0.2% (J Urol. 2011. 185[3];869-875). However, the key issue, according to Crawford, is whether all of these patients actually needed the surgery. The treatment is associated with serious comorbidities (eg, urinary incontinence and sexual dysfunction), and research has demonstrated that active surveillance can be equally effective in the appropriate patients.

In the PIVOT trial, men with localized prostate cancer were randomized to radical prostatectomy or observation. The results showed that there was no significant difference between the two approaches in terms of prostate-cancer mortality (N Engl J Med. 2012;367[3]:203-213). Additionally, Crawford said, “If you look at the hazard ratios [in the PIVOT data] and focus on who might benefit, what is seen is that with most low-risk cancers…[outcomes were] powerfully in favor of observation.”

Other clinical trial results have supported use of active surveillance, as well. According to Crawford, if you pool the results from the key active surveillance trials, you can collect data from nearly 3000 men with a reasonable follow-up period. Among these men, the cancer-specific survival rate at 10 years is 99.7%.

The one drawback with this evidence, Crawford noted, is that the data are retrospective. A definitive randomized trial was attempted by US and Canadian researchers; however, the study failed due to an inability to accrue patients.

Identifying Candidates for Active Surveillance

Crawford said that patient selection is paramount to successful outcomes with active surveillance. Although there are no standard guidelines for identifying ideal candidates, a few widely-used methodologies have emerged.

One is the D’Amico classification, developed by Anthony V. D’Amico, MD, PhD, Dana-Farber/Harvard Cancer Center. D’Amico’s criteria include a Gleason score ≤6, a PSA ≤10, and a tumor stage of T1c-2a (JAMA. 1998;280[11]:969-974).

Another popular set of criteria was developed by Jonathan Epstein, MD, at The James Buchanan Brady Urological Institute at Johns Hopkins. Epstein’s more refined standards include a Gleason score ≤6, stage T1c cancer, a PSA density <0.15, <3 cores with cancer, “and/ or cancer involving no more than 50% of any core on at least a 12 core biopsy.”

The NCCN Prostate Cancer Guidelines factor age into these classifications as well: life expectancy <10 years when using D’Amico criteria and <20 years when using Epstein criteria.

Other factors involved when considering active surveillance include the general health of the patient, side effects associated with treatment, and the patient’s personal preference.

Table. When Is Active Surveillance Appropriate?1

Risk Expected Survival Initial Therapy
Very Low (Epstein Criteria)2
Low (D’Amico Criteria)3
<20 years
<10 years
Active Surveillance Preferred4
Very Low (Epstein Criteria)2
Low (D’Amico Criteria)
≥20 years
≥10 years
1. Active Surveillance5
2. Radiotherapy
3. Radical Prostatectomy
1Based on NCCN Guidelines.
2Stage T1c; Gleason ≤6; PSA <10 ng/mL; <3 positive prostate biopsy cores, ≤50% cancer in any core; PSA density <0.15 ng/mL/g.
3Stage T1-T2a; Gleason ≤6; PSA <10 ng/mL.
4Monitor patient’s PSA at least every 6 months and do DRE at least every 12 months. For Very Low risk also do a repeat prostate biopsy as often as every 12 months.
5Monitor patient’s PSA at least every 6 months, do DRE at least every 12 months, and do a repeat prostate biopsy as often as every 12 months.
Source: Crawford ED. Active surveillance: pros, cons, and optimal candidates. Presented at: 6th Annual Interdisciplinary Prostate Cancer Congress; March 16, 2013; New York, NY.

 

Following Patients and Triggers for Intervention

There are no standard guidelines for how to follow patients on active surveillance or when to intervene with treatment.


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