PURPOSE: To identify risk factors for pathological progression among men on active surveillance (AS) in REDEEM.
MATERIALS AND METHODS: REDEEM was a 3-year, randomized, double-blind study of patients in 65 North American academic centers. Eligible men were 48-82 years old; with low-risk prostate cancer (T1c-T2a), Gleason score ≤ 6, ≤ 3 cores positive, tumor < 50% of any one core; serum prostate-specific antigen (PSA) ≤ 11 ng/mL; life expectancy >5 years; undergoing AS. Entry biopsies (≥10 cores) were required. The analysis included 276 patients with ≥1 biopsy after the start of study treatment. Patients received dutasteride 0.5 mg/day or placebo for 3 years. Time to pathological progression (volume [≥4 cores positive or ≥50% of one core] or grade progression [Gleason score ≥7]) in a post-baseline biopsy (not preceded by therapeutic intervention), and baseline variables were analyzed using a Cox proportional hazard model.
RESULTS: In total, 94/276 patients with a post-baseline biopsy (34.1%) progressed pathologically; 54 (19.6%) had volume progression only, 19 (6.9%) had grade progression only and 21 (7.6%) had both. Older age (HR: 1.05, 95% CI 1.01-1.08, P=0.009) and higher PSA density (HR: 1.06, 95% CI 1.04-1.09, P< 0.001) were associated with pathological progression. Post-baseline PSA identified grade, but not volume progression in placebo- and dutasteride-treated patients.
CONCLUSIONS: Older age and higher PSA density were independent predictors for pathological progression. Post-baseline measurements as predictors of pathological progression could not be established. Further studies are needed to evaluate the role of dutasteride and establish better markers of pathological progression in AS.
Written by:
Margel D, Nandy I, Wilson TH, Castro R, Fleshner N. Are you the author?
Division of Urology, Department of Surgical Oncology, Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada.
Reference: J Urol. 2013 Jun 29. pii: S0022-5347(13)04668-5.
doi: 10.1016/j.juro.2013.06.051
PubMed Abstract
PMID: 23820059
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