Finnish Multicenter Study Comparing Intermittent To Continuous Androgen Deprivation For Advanced Prostate Cancer

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology
Article Date: 02 Sep 2008 - 1:00 PDT

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UroToday.com - The FinnProstate Study VII (FPVII) is conducted as an open-label, randomized, controlled, parallel-group, multicenter clinical trial comparing intermittent and continuous ADT in patients with advanced PC. The primary objective is to compare the efficacy of IAD with continuous androgen deprivation (CAD) in terms of time to progression, and to evaluate whether IAD could prolong the hormone sensitivity of the cancer. Secondary objectives are to compare IAD and CAD in terms of overall and PC-specific survival, time to treatment failure, and to assess any differences in QoL aspects between the 2 treatment arms. In this interim analysis we evaluated which prognostic markers affect initial response to ADT. We identify patients with advanced PC whose prostate cancers are hormone sensitive and who might benefit from IAD. Therefore, all recruited patients were uniformly treated following the same protocol for 24 weeks in order to ensure hormone sensitivity of the cancer. Only patients with hormone sensitive PCa were randomized either to IAD or CAD. To meet the randomization criteria and to show hormone sensitivity, PSA had to be decreased to <10.0 ng/ml or at least by 50% if the baseline value at visit 1 was <20.0 ng/ml.

Statistical significance for this report was examined using both student's t-test and logistic regression multivariate analysis. All statistical tests were two-sided and a p-value below 0.05 was considered to indicate significance.

The duration of the run-in ADT (24 weeks) is a matter of debate, and there is controversy about the criteria for withdrawal and reintroduction of therapy. Our treatment regimen of 24 weeks seems appropriate, when comparing with previous studies. The reason to use higher PSA limit <10.0 ng/ml or <50% of the baseline in our study was the fact that there was not any evidence based data on the right PSA value which should be used in patients with advanced PC and high PSA levels.

Two hundred and ninety-two patients (34%) could not be randomized (group A), 564 patients (66%) completed the run-in period and fulfilled the randomization criteria (group B). Mean and median PSA, mean and median ALP, proportion of T4 tumors, proportion of poorly differentiated cancers, proportion of metastatic disease, and the number of skeletal hot spots among M1 patients were significantly higher in group A than in group B in the t-test analysis and in the logistic regression multivariate analysis. The testosterone values were slightly lower in group A at entry but higher at the time of randomization, although the difference was insignificant (p=0.180) in multivariate analysis. (So, the differences were identified between patients with hormone-non-sensitive and hormone-sensitive PCa, not between IAD and CAD groups.) In this study any low limit of testosterone at baseline was not defined as an exclusion criterion because we aimed to recruit in the study patients representing the whole advanced PC population treated with ADT. Patients with advanced PC having a high PSA, ALP, and metastatic disease with more than 5 skeletal hot spots do not show adequate biochemical PSA response to ADT and so they are not candidates for IAD, either.

Written by Arto J. Salonen, MD, as part of Beyond the Abstract on UroToday.com

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