Treatment of ED in Patients Treated for Prostate Cancer

描述（由申请人提供）：抗雄激素通常与 放射治疗（RT）或手术作为新辅助、辅助或同时 治疗，试图减少疾病复发和提高生存率。 然而，抗雄激素治疗的最佳组合和时机仍然存在， 争议放射治疗肿瘤组（RTOG）最近启动了一项 III期临床试验，RTOG 99 - 10，研究最佳持续时间 新辅助完全雄激素抑制（TAS）和RT治疗II-III期前列腺 癌然而，QGL降低，特别是与 性功能，将伴随着改善的临床结果与 TAS。具体来说，TAS和RT对勃起功能有显著影响。 如果干预措施可用于治疗勃起功能障碍（艾德）， 在前列腺癌治疗中，QOL损害可以最小化。西地那非（伟哥 TM，Pfizer）是FDA批准的用于治疗ED的药物。 非随机;单机构研究显示了显著改善 在RT后接受西地那非治疗的男性艾德中， 西地那非与RT和TAS联合治疗艾德， 没有被充分描述。传统观点认为，在RT+之后， 新辅助或同时TAS，勃起功能将等同于 单独RT后（TAS停药后）。然而，我们观察到， RT和TAS联合治疗的艾德率（即使在抗雄激素治疗后） 在我们的初步工作中，与单独的RT相比，雄激素 影响勃起功能通过不同的机制比病因 以前研究过。如果西地那非在这种情况下有效， 在关于治疗选择的患者决策和在临床上， 治疗后ED的管理。由于大多数前列腺癌患者 性伴侣，性体验的关键部分，目前缺乏的 文献，是对可能与艾德相互作用的关系因素的评估 预测或改变对治疗的反应。这些知识将使 基于临床策略的更有效的治疗方法， 提供关于药物的技术使用以及 创造适当的性心理环境的重要性。本研究 针对从RTOG 99 - 10招募参与研究的男性（N = 332），接受 新辅助TAS和RT 8周或28周，同时（8周 持续时间）TAS。本研究的主要目的是在一个随机的， 双盲交叉研究，如果勃起有显著差异， 接受西地那非与安慰剂治疗的男性在RT+后的功能 用于前列腺癌的新辅助TAS。第二个目标是确定是否存在 在总体性功能和满意度方面， 与安慰剂相比，西地那非治疗的男性，第三和第四个目标是 评估伴侣性满意度和二人婚姻的差异， 本研究的西地那非组与安慰剂组之间的校正。最后， 本研究将评估与艾德治疗反应相关的因素， 年龄、治疗前性功能和烟草使用等。

DESCRIPTION (provided by applicant): Antiandrogens are often combined with radiation therapy (RT) or surgery as neoadjuvant, adjuvant or concurrent therapy in an attempt to decrease disease relapse and improve survival. However, the optimal combination and timing of antiandrogen therapy remains controversial. The Radiation Therapy Oncology Group (RTOG) recently activated a Phase III clinical trial, RTOG 99-10, to study the optimal duration of neoadjuvant total androgen suppression (TAS) and RT in stage II-III prostate cancer. However, it is possible that diminished QGL, particularly related to sexual function, will accompany the improved clinical outcomes associated with TAS. Specifically, TAS and RT have a significant impact on erectile function. If interventions are available to treat erectile dysfunction (ED) after prostate cancer therapy, QOL impairments may be minimized. Sildenafil (Viagra TM, Pfizer) is a FDA approved drug for the treatment of ED. Small, nonrandomized; single institution studies have shown significant improvements in ED in men treated with sildenafil after RT. However, the effectiveness of sildenafil for ED as a consequence of combined treatment with RT with TAS has not been adequately described. Conventional wisdom held that after RT plus neoadjuvant or concurrent TAS, erectile function would be equivalent to that after RT alone (once the TAS are discontinued). However, we observed a higher ED rate with the combination of RT and TAS (even after the antiandrogens were discontinued) compared with RT alone in our preliminary work. Antiandrogens affect erectile function through a different mechanism than the etiologies previously studied. If sildenafil is efficacious in this setting, it may assist in both patient decision-making regarding choice of therapy and in clinical management of post-therapy ED. Since most men with prostate cancer have partners, a critical part of the sexual experience, currently lacking in the literature, is an assessment of relationship factors that may interact with ED therapy to predict or modify response to treatment. This knowledge would allow for more effective treatment approaches based on a clinical strategy that provides instruction both on the technical use of the medication as well as on the importance of creating an appropriate psychosexual environment. This study targets men (N=332) recruited for participation from RTOG 99-10, treated with either 8 or 28 weeks of neoadjuvant TAS and RT with concurrent (8 week duration) TAS. The primary aim of this study is to determine, in a randomized, double-blind crossover study, if there is a significant difference in erectile function between men treated with sildenafil versus placebo after RT plus neoadjuvant TAS for prostate cancer. The secondary aim is to determine if there is a significant difference in overall sexual function and satisfaction between men treated with sildenafil versus placebo, and the third and fourth aims are to assess differences in partner sexual satisfaction and dyad marital adjustment between the sildenafil versus placebo arms of this study. Lastly, this study will assess factors associated with response to ED therapy such as age, pre-treatment sexual functions, and tobacco use among others.