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Eight-Month Neoadjuvant Hormonal Therapy Not Superior to 3 Months for Decreasing PSA Recurrence: Presented at AUA

By Jill Stein

CHICAGO, IL -- April 28, 2003 -- Patients with prostate cancer who receive an 8-month or 3-month course of neoadjuvant hormonal therapy before radical prostatectomy appear to have similar rates of recurrence of high prostate-specific antigen (PSA) levels.

Researchers led by Dr. Martin Gleave with the University of British Columbia in Vancouver evaluated a cohort of men with clinically documented prostate cancer who were randomized to treatment with leuprolide 7.5 mg intramuscularly per month plus oral flutamide 250 mg 3 times daily for 3 or 8 months before undergoing radical prostatectomy.

Dr. Gleave presented the results of a phase III trial on behalf of the Canadian Uro-Oncology Group here April 27^th at the 2003 Annual Meeting of the American Urological Association.

The study's primary end point was disease-free survival, defined as a PSA level less than 0.4 ng/mL at 36 months.
The investigators previously reported that the study found that presurgery PSA nadir levels (0.052 ng/mL versus 0.12 ng/mL, P<0.001) and positive margin rates (12% versus 23%, P=0.0105) were lower in the 8-month group than in the 3-month group.

The latest analysis also showed that there were no significant differences in PSA recurrence rates at 4 years postsurgery. The overall PSA recurrence rates in 502 evaluable patients were 23.6% in the 8-month and 25.4% in the 3-month group (P=0.6398 by chi-square and P=0.0511 by log-rank test).

Subgroup analysis suggested reduced PSA recurrence in intermediate-risk patients only in high-volume centers.

Dr. Gleave said that future trials should evaluate the role of adjuvant versus neoadjuvant regimens in this setting.

The study was funded by Abbott Canada and TAP Pharmaceuticals.


[Study title: Randomized Comparative Study of 3 vs 8 Months of Neoadjuvant Hormonal Therapy Prior to Radical Prostatectomy: 3 Year PSA Recurrence Rates. Abstract 690]

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