Prospective phase II trial of permanent seed implantation prostate brachytherapy for intermediate-risk localized prostate cancer: efficacy, toxicity, and quality of life outcomes
Mené sur 300 patients atteints d'un cancer de la prostate de stade inférieur ou égal à cT2b et traité entre 2006 et 2013 (âge médian : 64,9 ans ; durée médiane de suivi : 5,1 ans), cet essai de phase II évalue l'efficacité, du point de vue notamment de l'absence d'échec biochimique et de la survie globale à 5 ans, et la toxicité d'une curiethérapie avec implants permanents de grains radioactifs
Background : Brachytherapy monotherapy is a treatment option for intermediate-risk localized prostate cancer but published prospective data are scarce. Methods : Prospective phase II trial of 300 patients with previously untreated prostate cancer treated between 2006–2013. Eligible patients had ≤cT2b (T3 excluded based on magnetic resonance imaging), Gleason score [GS]=6 and prostate-specific antigen [PSA] level 10-15 ng/mL, or GS=7 and PSA<10 ng/mL, and were treated with prostate brachytherapy (without hormonal therapy). Results : Median patient age was 64.9 years; 3.7% had GS 6, 78.7% had GS 7(3+4), and 17.7% had GS 7(4+3). Median follow-up time was 5.1 years. Median PSA at 5 years was 0.01 ng/mL (range 0–6.0). Ten biochemical failures occurred, for a 5-year freedom from biochemical failure rate of 97.3% (95% confidence interval [CI] 95.1%, 99.5%), and 16 patients died, only one from prostate cancer, for 5-year rates of overall and biochemical progression-free survival of 94.9% (95% CI 92.1%, 97.9%) and 92.7% (95% CI 89.3%, 96.2%). Four patients had late grade 3 genitourinary toxicity and two late grade 3 rectal toxicity; no grade 4 or 5 toxicity was observed. Rates of “moderate or big problems” at 4 years were 7.4% for urinary (vs. 0.4% baseline), 2.9% bowel (vs. 0.4%), and 29.7% sexual function (vs. 19.7%). Most men were “satisfied or extremely satisfied” (91% at 2 years after treatment and 93% at 4 years). Conclusions : Brachytherapy monotherapy is safe, effective, and leads to good quality of life for select men with localized intermediate-risk prostate cancer.
http://www.redjournal.org/article/S0360-3016(17)33968-8/fulltext