Mayo Clinic, Rochester, Minnesota.
Radiation Therapy Oncology Group, Philadelphia, Pennsylvania.
JAMA. 2014 Apr 2;311(13):1300-7. doi: 10.1001/jama.2014.2626.
Tadalafil is used to treat erectile dysfunction after prostate cancer treatment, but its role as a preventive agent is undefined.
To determine primarily whether tadalafil preserved erectile function in men treated with radiotherapy for prostate cancer, and secondarily to determine whether participant- or partner-reported overall sexual function and sexual and marital satisfaction were affected.
DESIGN, SETTING, AND PARTICIPANTS: Stratified, placebo-controlled, double-blind, parallel-group study with 1:1 randomization at 76 community-based and tertiary medical sites in the United States and Canada. Two hundred forty-two participants with intact erectile function scheduled to receive radiotherapy for prostate cancer were recruited between November 2009 and February 2012 with follow-up through March 2013.
One hundred twenty-one participants were assigned 5 mg of tadalafil daily and 121 were assigned placebo for 24 weeks starting with external radiotherapy (63%) or brachytherapy (37%). Participant-reported International Index of Erectile Function response before radiotherapy and at weeks 2 and 4, between weeks 20 and 24, between weeks 28 and 30, and 1 year thereafter. Participants and partners could respond also to the Sexual Adjustment Questionnaire and to the Locke Marital Adjustment Test before radiotherapy, between weeks 20 and 24 and weeks 28 and 30, and at 1 year.
Primary outcome was off-drug spontaneous erectile function 28 to 30 weeks after radiotherapy started. Secondary end points were spontaneous erection at 1 year; overall sexual function and satisfaction; marital adjustment; and partner-reported satisfaction and marital adjustment at 28 to 30 weeks and 1 year, predictors of tadalafil response; and adverse events.
Among 221 evaluable participants, 80 (79%; 95% CI, 70%-88%) assigned to receive tadalafil retained erectile function between weeks 28 and 30 compared with 61 (74%; 95% CI, 63%-85%) assigned to receive placebo (P = .49); an absolute difference of 5% (95% CI, -9% to 19%). A significant difference was also not observed at 1 year (72%; 95% CI, 60%-84% vs 71%; 95% CI, 59%-84%; P = .93). Tadalafil was not associated with significantly improved overall sexual function or satisfaction; a significant difference was not observed in any domain subscale. Partners of men assigned tadalafil noted no significant effect on sexual satisfaction, and marital adjustment was not significantly improved in participants or partners.
Among men undergoing radiotherapy for prostate cancer, daily use of tadalafil compared with placebo did not result in improved erectile function. These findings do not support daily use of tadalafil to prevent erectile dysfunction in these patients.
clinicaltrials.gov Identifier: NCT00931528.
他达拉非用于治疗前列腺癌治疗后的勃起功能障碍，但作为预防剂的作用尚未确定。
主要确定他达拉非是否可预防接受前列腺癌放射治疗的男性发生勃起功能障碍，其次确定参与者或其伴侣报告的整体性功能和性及婚姻满意度是否受到影响。
设计、地点和参与者：在美国和加拿大的 76 个社区和三级医疗中心进行了分层、安慰剂对照、双盲、平行组研究，采用 1:1 随机分组，于 2009 年 11 月至 2012 年 2 月间招募了 242 名有完整勃起功能的患者，随访至 2013 年 3 月。
121 名参与者被分配 5mg 他达拉非，每日一次，121 名参与者被分配安慰剂，在开始外部放射治疗（63%）或近距离放射治疗（37%）前 24 周开始使用。参与者在放射治疗前、第 2 周和第 4 周、第 20 周和第 24 周、第 28 周和第 30 周、以及此后 1 年报告国际勃起功能指数（International Index of Erectile Function）的反应。参与者和伴侣还可以在放射治疗前、第 20 周和第 24 周及第 28 周和第 30 周以及 1 年后回答性调整问卷（Sexual Adjustment Questionnaire）和洛克婚姻调整测试（Locke Marital Adjustment Test）。
主要结局是放射治疗开始后 28 至 30 周时停药后自发勃起功能。次要终点是 1 年后的自发勃起；整体性功能和满意度；婚姻调整；以及伴侣在第 28 至 30 周和 1 年后报告的满意度和婚姻调整、预测他达拉非反应的因素；以及不良事件。
在 221 名可评估的参与者中，80 名（79%；95%CI，70%-88%）接受他达拉非治疗的患者在第 28 至 30 周期间保留了勃起功能，而 61 名（74%；95%CI，63%-85%）接受安慰剂治疗的患者保留了勃起功能（P=0.49）；绝对差异为 5%（95%CI，-9%至 19%）。1 年后也未观察到显著差异（72%；95%CI，60%-84%与 71%；95%CI，59%-84%；P=0.93）。他达拉非与整体性功能或满意度的显著改善无关；任何领域的子量表都没有显著差异。接受他达拉非治疗的男性的伴侣注意到性满意度没有显著影响，参与者或伴侣的婚姻调整也没有显著改善。
在接受前列腺癌放射治疗的男性中，与安慰剂相比，每日使用他达拉非并没有改善勃起功能。这些发现不支持在这些患者中使用他达拉非来预防勃起功能障碍。
clinicaltrials.gov 标识符：NCT00931528。
