BERLIN, GERMANY (UroToday) - Dr. Kurt Miller, Professor of Urology at Univsitätsmedizin, Berlin, discussed the use of androgen deprivation therapy in patients with prostate cancer. He presented the results of a randomized prospective trial, (AU0 AP 17/95), comparing intermittent and continuous androgen suppression in advanced prostate cancer.

Between 10/97 and 6/06, 335 patients were randomized. Among those with M (+) disease to bone, 41% with a median PSA of 158 ng/ml were randomized to intermittent therapy and 35% with a median PSA of 139 ng/ml were randomized to continuous androgen deprivation.

With a median follow-up of 50.5 months, 108/165 patients, 65%, in the intermittent arm and 113/170 patients in the continuous arm progressed. For the patients on the intermittent arm, 88% of the patients were off therapy for greater than 50% of the time, but the time off therapy with a normal testosterone was not specified. The average time to normalization of serum testosterone was 70 days.

Importantly, the results of this randomized prospective trial indicated that there was no difference in progression-free survival or overall survival. There may have been a small advantage in quality of life for patients on the intermittent arm but there was no difference in adverse events. Dr. Miller also referenced a Phase III intermittent (maximal androgen blockade (MAB) vs. continuous MAB study presented by da Silva at ASCO in 2006 (abstract # 4513). Six hundred twenty-six patients were randomized with 70% of the patients in this study being M0. The results indicated no difference in either progression free or overall survival. This study demonstrated better quality of life in the intermittent arm and more cardio-vascular events in the continuous arm.

Dr. Miller indicated that, in his opinion, the ideal candidate for intermittent androgen deprivation therapy presents with low volume disease, a rising PSA, and documented progression after discontinuation of adjuvant hormonal therapy. In the presence of metastatic disease, Dr. Miller noted that all patients should have a PSA nadir

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