Defining PSA response

Investigators participating in new prostate cancer drug trials commonly define PSA response according to the Bubley guidelines [35] for phase II clinical trials in androgen-inde-pendent prostate cancer. The guidelines qualify the following categories of PSA: PSA normalization, PSA <=0.2 ng/ml; PSA decrease, PSA decline >50%, confirmed by a second PSA value 4 or more weeks later; PSA progression, PSA >25% increase over the baseline (and an increase in the absolute value PSA level by at least 5 ng/mL). Though useful for evaluating clinical trials, these PSA changes lack sensitivity when evaluating subtle drug effects vs. prostate tumor growth [36,37, 38].

Therasse [39, 40], in his thesis reports on MRI and PSA as tools in a RECIST evaluation used to define tumor response in prostate cancer patients with measurable soft tissue lesions. When comparing MRI soft tissue responses to serum PSA changes, the correlation of PSA and MRI showed agreement in 14 of the 20 (70%) patients.

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