There are two groups of men in whom active surveillance is considered most appropriate, those at very low risk and those at low risk of disease progression, as outlined below.
|Very low||PSA <10||Gleason Score <7 and stage T1c and PSA density <0.15 and unilateral disease with <3 cores containing cancer regardless of percent core involvement||
Any age if patient prefers surveillance
|PSA 10-20||Gleason Score <7 and stage T1c and PSA density <0.10 and unilateral disease with <3 cores containing cancer regardless of percent core involvement||
Any age if patient prefers surveillance
Preferred if life expectancy is less than 20 years
|Low||Stage T1c or T2a and Gleason score <7 and PSA <10||
Age >65 years
Preferred if life expectancy is less than 10 years
|Intermediate||T2 or PSA 10-20 or Gleason score 3+4||Life expectancy is less than 10 year|
|High||Stage T3 or Gleason score >3+4 or PSA >20||Not recommended|
Gleason refers to Gleason scores.
PSA density is PSA divided by prostate volume determined by ultrasound or MRI (magnetic resonance imaging)
Stage T1c (no abnormality on rectal examination)
Stage T2 (palpable abnormality within prostate)
Stage T3 (palpable abnormality outside prostate)
Let’s take a closer look at each of the categories.
Primarily men in the very low or low-risk groups are candidates for active surveillance at Johns Hopkins. Candidates may also include those with intermediate risk disease and limited life expectancy, or those with intermediate risk disease that have a strong preference for avoiding treatment. The latter two groups may be enrolled provided they understand there is a higher risk of harm without treatment when compared to men with very low to low risk.
Currently, 70% of men in the Johns Hopkins Active Surveillance Program have very low risk disease, and 30% have low risk disease. We recommend that the majority of candidates for the program have an MRI-guided biopsy of their prostate gland to help determine the safety of surveillance (see sidebar).
Fusion of MRI and Ultrasound for targeted biopsies
Advances in computer technology now allow a 3-dimensional rendering of the prostate as imaged by MRI and ultrasound to be aligned or fused. This provides the physician with the ability to target areas of the prostate suspicious on MRI using live ultrasound. As compared to non targeted biopsies that sample the prostate systematically under ultrasound guidance alone, targeted biopsies are more likely to uncover high grade cancers.
The value of targeted biopsies in surveillance is two fold.
First, improving the selection of men that have low grade cancer, by reducing the chance that a high grade cancer was missed on a non targeted biopsy. This may improve the safety of surveillance.
Second, MRI reduces the frequency of monitoring biopsies in those men that have no suspicion of cancer on MRI.
Very low-risk: Characteristics of a man considered to be at very low risk for progression of his prostate tumor would include a low prostate specific antigen density (PSAD; see sidebar) indicating that his PSA is appropriate for the volume of the prostate, a Gleason score (see sidebar) of less than 7, less than 3 cores of tissue from the biopsy showing cancer, and unilateral cancer (cancer found on only one side of the prostate either right or left (see modified Epstein criteria). Surveillance would be the preferred option for these men if life expectancy is less than 20 years, which would include most men over age 65 years.
Low-risk: Characteristics of a man considered to be at low risk for progression of his prostate tumor would include a Gleason score of less than 7, a PSA measurement of less than 10, and stage T1c or T2a disease. Surveillance would be the preferred option for men with low risk prostate cancer that have less than a 10 year life expectancy; and should be considered for men over age 65 years.
Modified Epstein Criteria
In 1994, Jonathan Epstein and colleagues at Johns Hopkins described the prostate biopsy criteria for predicting the presence of a small volume low grade cancer within prostates removed surgically for treatment of prostate cancer.
The idea was to identify men that could safely forego surgery and enroll in active surveillance before removing the prostate.
The criteria that were predictive of small volume (cancer less than 0.5cc) and low grade (Gleason score 6) prostate cancer at radical prostatectomy were a PSA density below 0.15, and a prostate biopsy showing low grade cancer (Gleason score 6) that was small volume on biopsy (no more than 2 cores with cancer and no more than 50% involvement of any tissue core involved with cancer).
In a study published in 2014 the original criteria have been modified with the presence of a unilateral cancer (cancer on only one side of the prostate either right or left) replacing the percentage of the tissue core involved with cancer. The current criteria that are referred to as very low risk include a PSA density below 0.15, Gleason score 6 on prostate biopsy, no more than 2 cores of tissue with cancer that is located on one side of the prostate on biopsy.
Men who meet these criteria are considered at very low risk of harboring aggressive prostate cancer and could be considered the most ideal candidates -but not the only candidates -for active surveillance.
Men who would like to participate in active surveillance must also be comfortable living with a 'wait and see' approach, knowing they are being carefully monitored so that physicians are prepared to intervene immediately if the tumor becomes more threatening, and also men who want to avoid consequences of treatment that may include urinary incontinence and sexual dysfunction.
What’s required for follow-up? Periodic measurements of PSA and prostate biopsies are necessary. If the PSA rises rapidly or there are changes the pathologist identifies on the biopsy that indicate rapid progression, these would be triggers for further evaluation and possibly intervention.
What are the risks of participating in active surveillance?
Your risk of undetected prostate cancer progression is extremely low. Risks that have been identified in some programs largely result from misclassification of your tumor at the time of diagnosis, where the cancer is aggressive and associated with death from prostate cancer at 15 years after treatment. Current literature suggests that this may occur in 2-3% of cases. Right now a host of molecular markers and imaging techniques are in development to reduce this number further.