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- W2068272541 abstract "Purpose/Objective: To evaluate the effect of 3 months vs 8 months neoadjuvant hormone therapy (NHT) prior to standard dose radiotherapy (RT) on biochemical disease free rates (bNED as defined by the ASTRO consensus) and biopsy proven eradication of local disease for clinically localized prostate cancer. Materials/Methods: From 02/95 to 06/01, 369 patients with clinically localized prostate cancer were randomized to either 3 months or 8 months of Flutamide plus Zoladex prior to standard dose external beam radiotherapy (66 Gy) at 4 participating centers (3 mo. n=182, 8 mo. n =187). Median age was 71 (range 49-84). Stage distribution was 18% T1c, 35% T2a, 35% T2b/c, 12% T3 and 0.5% T4. Gleason score was 50% < 7, 38% = 7, and 11% 8-10. Median baseline PSA at presentation was 9.7 ng/ml (range 1.3–189). The 2 arms were balanced in terms of age, Gleason score, T stage and presenting PSA. Median followup is 23 months (range 6–57). Results: The 8 month arm achieved a lower PSA prior to starting RT (median 0.16 vs 0.3 ng/ml, p < 0.001) and had more downsizing of the prostate (median volume 21.5 cc vs 25.0 cc, p=0.02). However, the actuarial freedom from failure rate at 3 years is 65% for the 3 month arm and 64% for the 8 month arm. There is no difference in the pattern of failures between the 3 month and 8 month arms: biopsy only 2.3% vs 2.8%, biochemical 12% vs 15.3%, local 6.3% vs 4.5%, and distant 1.7% vs 2.8%. Two year post RT biopsies have been completed in 43% of patients (n=159). Negative biopsies were achieved in 66% of the 3 month patients and 74% of the 8 month, while 16.1% and 9.7% had indeterminate biopsies, and 18.4% and 16.7% were positive for residual disease (p=0.4). Conclusions: A longer period of NHT prior to standard dose RT does not appear to confer a benefit in terms of disease free rates, or alter failure patterns in the short term. Additional followup is required to determine the true efficacy of the 2 treatment arms." @default.
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- W2068272541 date "2002-10-01" @default.
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- W2068272541 title "Preliminary report of a multi center canadian phase III randomized trial of 3 months vs 8 months neoadjuvant androgen ablation prior to standard dose radiotherapy for clinically localized prostate cancer" @default.
- W2068272541 doi "https://doi.org/10.1016/s0360-3016(02)03288-1" @default.
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