Active surveillance with curative intent appears to be a safe alternative to immediate intervention with surgery or radiation for men with low-risk prostate cancer (PCa), according to researchers.
The study, published online ahead of print in the Journal of Clinical Oncology, is believed to be the largest and longest study of its kind. A total of 769 PCa patients were followed prospectively on active surveillance. The median follow-up was 2.7 years (range 0.01 -15.0 years). To be included in the study, men had to have very low-risk cancers, defined by clinical stage (T1c), PSA density less than 0.15 ng/mL, and prostate biopsy findings (Gleason score of 6 or less, two or fewer cores with cancer, and 50% or less cancer involvement in any core).
None of the men, who were mostly aged 65 years and older, have so far died from PCa since the study began in 1995. However, 255 men (33.2%) eventually underwent treatment at a median 2.2 years after diagnosis; of these, 188 (73.7%) underwent intervention because of disease reclassification on biopsy.
“The study offers the most conclusive evidence to date that active surveillance may be the preferred option for the vast majority of older men diagnosed with a very low grade or small volume form of prostate cancer,” said senior investigator H. Ballentine Carter, MD, Professor of Urology at Johns Hopkins School of Medicine in Baltimore.
The primary outcome was survival free of intervention; secondary outcomes were rates of disease reclassification and exit from the study. Men who strictly met all study criteria for very low-risk disease were 30% less likely to be reclassified to a high-risk category during surveillance and less likely to need subsequent surgery or radiation than men who did not meet one or more study criteria.