INTRODUCTION AND OBJECTIVES: Between 2/92 and 3/94 a prospective, randomized, multi-institutional trial was conducted to evaluate the efficacy of 3 months of androgen deprivation (AD) prior to radical prostatectomy (RP) in men with cT2b (B2) prostate cancer. AD consisted of leuprolide acetate depot 7.5 mg monthly plus flutamide 250 mg p.o. q8h. A fourth dose of leuprolide was given 48 hours prior to RP. The incidence of tumor at the inked margin was significantly lower in the pretreated group, 18% vs 48% (p< 0.001). PSA levels have been monitored and are available on all evaluable patients through 24 months. METHODS: The 2-year PSA data was analyzed for 256 evaluable patients; 129 pre RP AD and 127 RP alone. A PSA> 0.4 was considered an indicator of recurrent prostate cancer. Survival analysis methodology was used to estimate relapse rates and to test for differences between subgroups. RESULTS: 27 evaluable patients in each group have relapsed. This represents 21.0% in the pretreated patients and 21.6% who underwent RP alone (P= 0.909). A positive margin was associated with a higher relapse rate in both groups (PSA> 0.4). Percent of patients (± SE) with a PSA> 0.4 by treatment group and margin status is as follows: M+ M- P value AD→RP 47% 12.2% 17% 3.7% 0.019 RP alone 31% 6.5% 13% 4.3% 0.023 Tumor extension to the seminal vesicles was associated with an equally high recurrence rate in both groups, pre RP AD 67%, RP alone 65%. 75% of the 11 pts with positive nodes have had biochemical recurrence at 2 yrs. CONCLUSION: A 24 month follow up.on evaluable patients from the US T2b Study indicates an identical recurrence rate (PSA> 0.4 ng/ml) 21% in both groups.
|Original language||English (US)|
|Number of pages||1|
|Journal||British Journal of Urology|
|Issue number||SUPPL. 2|
|State||Published - Dec 1 1997|
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