Fleshner Neil, Gomella Leonard G, Cookson Michael S, Finelli Antonio, Evans Andrew, Taneja Samir S, Lucia M Scott, Wolford Eric, Somerville Matthew C, Rittmaster Roger
University Health Network, Princess Margaret Hospital, Toronto, ON, Canada.
Contemp Clin Trials. 2007 Nov;28(6):763-9. doi: 10.1016/j.cct.2007.05.006. Epub 2007 May 29.
Men with prostate cancer may live as long as men their age without prostate cancer. Those with low-risk disease may benefit from expectant management, which actively monitors disease progression. Dutasteride, a dual 5alpha-reductase inhibitor (5ARI), may delay prostate cancer progression or extend the time to initiation of more aggressive therapy.
The Reduction by Dutasteride of Clinical Progression Events in Expectant Management (REDEEM) trial will evaluate whether dutasteride decreases time to prostate cancer progression. Three hundred candidates for expectant management with biopsy-proven, low-risk, localized prostate cancer will receive dutasteride 0.5 mg/day or placebo for 3 years. Eligible men are between 50 and 80 years of age, have clinical stage T1c-T2a prostate cancer, a Gleason score of less than or equal to 6, and serum prostate-specific antigen (PSA) less than or equal to 10 ng/mL. Entry biopsy of at least 10 cores had to be performed within 6 months of screening and will be repeated at 1.5 and 3 years. Men will complete questionnaires to measure symptoms, quality of life (QOL), and anxiety. Because PSA is an important monitoring tool in expectant management that may impact patients' comfort levels, actual PSA values will be provided to physicians and subjects. Time-to-disease progression (primary therapy for prostate cancer or pathologic progression), positive cores, change in Gleason score, and QOL assessments will be compared between groups.
The trial completed recruitment of 302 subjects in March 2007. The study will be completed in 2010.
The REDEEM study will evaluate the potential for dutasteride to delay disease progression in men with low-risk, localized prostate cancer. This study will better define which patients with prostate cancer can be managed with less invasive and potentially less debilitating therapy.
前列腺癌男性患者的生存期可能与同龄无前列腺癌男性相同。低风险疾病患者可能从观察等待管理中获益，该管理方式会积极监测疾病进展。度他雄胺，一种双重5α-还原酶抑制剂（5ARI），可能会延缓前列腺癌进展或延长开始更积极治疗的时间。
度他雄胺在观察等待管理中减少临床进展事件（REDEEM）试验将评估度他雄胺是否能缩短前列腺癌进展时间。300名经活检证实为低风险、局限性前列腺癌且适合观察等待管理的患者将接受0.5毫克/天的度他雄胺或安慰剂治疗3年。符合条件的男性年龄在50至80岁之间，临床分期为T1c - T2a期前列腺癌，Gleason评分小于或等于6，血清前列腺特异性抗原（PSA）小于或等于10纳克/毫升。必须在筛查后6个月内进行至少10针穿刺的初次活检，并在1.5年和3年时重复进行。男性患者将完成问卷以评估症状、生活质量（QOL）和焦虑情况。由于PSA是观察等待管理中的重要监测工具，可能会影响患者的舒适度，实际PSA值将提供给医生和受试者。将比较两组之间的疾病进展时间（前列腺癌的初次治疗或病理进展）、阳性穿刺针数、Gleason评分变化和QOL评估结果。
该试验于2007年3月完成了302名受试者的招募。研究将于2010年完成。
REDEEM研究将评估度他雄胺在低风险、局限性前列腺癌男性患者中延缓疾病进展的潜力。这项研究将更好地确定哪些前列腺癌患者可以采用侵入性较小且可能致残性较低的治疗方法进行管理。
