Treatment of ED in Patients Treated for Prostate Cancer

描述(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、辅助或同时进行 旨在减少疾病复发和提高存活率的治疗。 然而，抗雄激素治疗的最佳组合和时机仍然存在。 有争议的。放射治疗肿瘤学小组(RTOG)最近激活了一项 第三阶段临床试验，RTOG 99-10，以研究最佳持续时间 新辅助全雄激素抑制(TAS)和RT治疗II-III期前列腺癌 癌症。然而，QGL的减少是有可能的，特别是与 性功能，将伴随着临床结果的改善 助教。具体来说，TAS和RT对勃起功能有显著影响。 如果有干预措施可用于治疗勃起功能障碍(ED) 前列腺癌的治疗，对生活质量的损害可能会降到最低。西地那非(伟哥 TM，辉瑞)是FDA批准的治疗ED的药物。小的, 非随机化；单一机构研究显示显著改善 放疗后接受西地那非治疗的患者的ED。然而，这一政策的有效性 西地那非联合放疗与TAS治疗ED疗效观察 没有得到充分的描述。传统观点认为，在RT Plus之后 新辅助或并发TAS，勃起功能将等同于 仅在RT之后(一旦TA停止使用)。然而，我们观察到了更高的 RT和TAS相结合的ED率(即使在抗雄激素被 停产)与我们初步工作中仅使用RT进行比较。抗雄激素 影响勃起功能的机制与病因不同 以前研究过的。如果西地那非在这种情况下有效，它可能会有所帮助 在患者关于治疗选择的决策和临床上 治疗后ED的管理。因为大多数患有前列腺癌的男性 性伴侣，性体验的关键部分，目前在 文献，是对可能与ED相互作用的关系因素的评估 治疗预测或改变对治疗的反应。这一知识将使 基于临床策略的更有效的治疗方法 提供有关药物的技术用法以及 创造适当的性心理环境的重要性。本研究 目标男性(N=332)，从RTOG 99-10招募参加，接受治疗 8周或28周的新辅助TAS和RT，同时(8周 持续时间)TAS。这项研究的主要目的是确定，在一个随机的， 双盲交叉研究，勃起功能是否有显著差异 接受西地那非治疗的男性与接受RT+安慰剂治疗的男性之间的功能比较 前列腺癌的新辅助剂TAS。第二个目标是确定是否有 在总体性功能和满意度方面有显著差异 接受西地那非治疗的男性与安慰剂相比，第三和第四个目标是 评估伴侣的性满意度和二人婚姻的差异 这项研究中西地那非与安慰剂之间的调整。最后， 这项研究将评估与ED治疗反应相关的因素，如 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.