Trial of chemotherapy (CHT) plus hormonal therapy an initial treatment for prostate cancer (PC)

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14637 Background: The delivery of CHT in a setting of androgen-independent (AI) PC has demonstrated: survival benefit associated with a PSA decline and tolerable toxicity, thus strongly suggesting that disease modifying potential exists. Preclinical data supports the benefit of simultaneous CHT and androgen deprivation (AD). The stage is set for CHT to be given earlier in men with PC. Data suggests a transformation from an androgen-dependent to an AI phenotype is mediated by the expansion of an AI clone already present at the time of AD. If this model is correct, it would be feasible to bring CHT up front when the corresponding tumor burden is minimal. Methods: A course of CHT is defined as 8 weeks (6 on/2 off). The therapy consists of weeks 1, 3, and 5 with adriamycin 20 mg/m2 as a 24 hour intravenous infusion on the first day of every week in combination with ketoconazole 400 mg orally 3 times a day, daily for 7 days. Weeks 2, 4, and 6 treatment consisted of docetaxel 35 mg/m2 intravenously over 1 hour on the first day of every week in combination with estramustine 280 mg orally 3 times a day, daily for 7 days. Hormone therapy, GnRH antagonist, is initiated within the first 6 months of starting CHT. Following the completion of 3 courses of CHT, the addition of casodex occurs. Hormone management then continues for a total of 24 months, and then is discontinued. Patients (pts) are followed every 12 weeks with a PSA, testosterone and routine laboratory evaluation. For those men who have had a PSA recurrence, hormone therapy will be reinitiated. Results: 34 men have been enrolled to date. 47% of the men had no prior local therapy, while the other 35% had surgery, 15% had radiation therapy or 3% had both. 3% had a gleason 6, 41%/7, 26%/8, 27%/9 and 3%/10. 64% of the men presented with bone and/or nodal metastasis. Baseline median PSA was 11.2 (1.0–1065.5). The median PSA reduction to date has been 96% with associated nodal and bone scan improvement. Conclusion: Information regarding PSA response, radiographic outcome, toxicity and results of men who are discontinuing hormones will be presented. [Table: see text]