Overdiagnosis and subsequent overtreatment are important side effects of screening for, and early detection of, prostate cancer ( PCa ). Active surveillance ( AS ) is of growing interest as an alternative to radical treatment of low-risk PCa.
In the PRIAS study eligible patients had clinical stage T1/T2 prostate cancer, prostate-specific antigen ( PSA ) less than or equal to 10 ng/ml, PSA density less than 0.2 ng/ml per milliliter, one or two positive biopsy cores, and Gleason score less than or equual to 6.
PSA was measured every 3-6 months, and volume-based repeat biopsies were scheduled after 1, 4, and 7 years.
Reclassification was defined as more than two positive cores or Gleason more than 6 at repeat biopsy.
Recommendation for treatment was triggered in case of PSA doubling time less than 3 years or reclassification.
In total, 2494 patients were included and followed for a median of 1.6 years.
One or more repeat biopsies were performed in 1480 men, of whom 415 men ( 28% ) showed reclassification.
Compliance with the first repeat biopsy was estimated to be 81%.
During follow-up, 527 patients ( 21.1% ) underwent active therapy.
Active therapy-free survival ( ATFS ) at 2 years was 77.3%.
The strongest predictors for reclassification and switching to deferred treatment were the number of positive cores ( two cores compared with one core ) and PSA density.
The disease-specific survival rate was 100%.
Follow-up was too short to draw definitive conclusions about the safety of active surveillance.
In conclusion, these short-term data support active surveillance as a feasible strategy to reduce overtreatment. Clinical characteristics and PSA kinetics during follow-up can be used for risk stratification.
Strict monitoring is even more essential in men with high-risk features to enable timely recognition of potentially aggressive disease and offer curative intervention.
Limitations of using surrogate end points and markers in active surveillance should be recognized. ( Xagena )
Bul M et al, Eur Urol 2013;63:597-603