The Effect of Dutasteride on the Usefulness of Prostate Specific Antigen for the Diagnosis of High Grade and Clinically Relevant Prostate Cancer in Men With a Previous Negative Biopsy: Results From the REDUCE Study
The Effect of Dutasteride on the Usefulness of Prostate Specific Antigen for the Diagnosis of High Grade and Clinically Relevant Prostate Cancer in Men With a Previous Negative Biopsy: Results From the REDUCE Study
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DOI：
10.1016/j.juro.2010.09.011
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发表时间：
2011-01-01
影响因子：
6.6
通讯作者：
Rittmaster, Roger S.
中科院分区：
文献类型：
--
作者：
Andriole, Gerald L.;Bostwick, David;Rittmaster, Roger S.
目的：我们评估了度他雄胺是否可以增强总前列腺特异性抗原诊断临床意义上的前列腺癌的有效性。材料和方法：为期4年的REDUCE研究评估了每天0.5 mg度他雄胺对于前列腺特异性抗原为2.5至10.0 ng/ml且前列腺活检呈阴性的男性降低前列腺癌风险的有效性和安全性。评估前列腺特异性抗原诊断前列腺癌的特异性、敏感性、阳性预测值和阴性预测值。根据ROC曲线下面积评估，在接受度他雄胺的男性中，活检前最终前列腺特异性抗原和从第6个月到最终前列腺特异性抗原的变化对于Gleason评分7-10肿瘤的诊断更好（分别为0.700 vs 0.650，p = 0.0491; 0.699 vs 0.593，p = 0.0001）。前列腺特异性抗原的增加与活检可检测、Gleason评分7-10和临床显著（改良Epstein标准）前列腺癌的可能性较高相关。在度他雄胺组中，前列腺特异性抗原从基线到第6个月的百分比下降并不能预测前列腺癌的总体或Gleason评分7-10 cancer.Conclusions：在既往前列腺活检阴性的男性中，前列腺特异性抗原在4年的研究中表现更好，作为接受度他雄胺与安慰剂的男性中前列腺癌的标志物。与安慰剂组相比，度他雄胺组6个月后前列腺特异性抗原升高的程度是临床显著癌症的更好指标。相反，服用度他雄胺的男性前列腺特异性抗原最初降低并不能预测前列腺癌的可能性。
Purpose: We assessed whether dutasteride enhances the usefulness of total prostate specific antigen for diagnosing clinically significant prostate cancer.Materials and Methods: The 4-year REDUCE study evaluated the efficacy and safety of 0.5 mg dutasteride daily for prostate cancer risk reduction in men with a prostate specific antigen of 2.5 to 10.0 ng/ml and a negative prostate biopsy. Specificity, sensitivity, and positive and negative predictive values of prostate specific antigen for the diagnosis of prostate cancer were assessed.Results: Final prostate specific antigen before biopsy and change from month 6 to final prostate specific antigen performed better for the diagnosis of Gleason score 7-10 tumors in men who received dutasteride vs placebo as assessed by the area under the ROC curves (0.700 vs 0.650, p = 0.0491; and 0.699 vs 0.593, p = 0.0001, respectively). Increases in prostate specific antigen were associated with a higher likelihood of biopsy detectable, Gleason score 7-10 and clinically significant (modified Epstein criteria) prostate cancer. Percentage decreases in prostate specific antigen from baseline to month 6 in the dutasteride arm did not predict prostate cancer overall or Gleason score 7-10 cancer.Conclusions: In men with a previously negative prostate biopsy, prostate specific antigen performed better during the 4-year study as a marker of prostate cancer in men who received dutasteride vs placebo. The degree of prostate specific antigen increase after 6 months was a better indicator of clinically significant cancer in the dutasteride arm than in the placebo arm. Conversely, the initial decrease in prostate specific antigen in men taking dutasteride did not predict the likelihood of prostate cancer.