Improving Quality of Life of Prostate Cancer Survivors with Androgen Deficiency

摘要 本申请要求结清资金，以完成试验和 完成项目的拟议目标。这一计划中的审判延期， 在过去两年中，曾多次与试验的dsmb讨论过 以及项目工作人员，因为全国范围内暂停 由于新冠肺炎大流行的爆发，2020年将开展临床研究活动。连 在全面暂停非Covid临床研究活动解除后， 2020和2021年临床研究活动随后大幅增加 由于与COVID相关的限制和其他原因，慢于大流行前的时期 研究策略部分中描述的原因。这些与CoVID相关的 限制大大减慢了参与者的注册速度，并推迟了 审判。随着这些与Covid相关的限制在过去一年中逐步取消， 以及研究小组实施的一些步骤，这些步骤在 研究战略科，包括在布雷迪增加第二个审判地点 约翰·霍普金医疗机构的泌尿学中心；增加人员努力 参与者筛选；以及DSMB建议的资格标准修订， 参加试验的人数大幅增加，平均每个随机试验6次 在过去的几个月里，这是一个月。如研究策略部分所述， 截至2022年12月31日，已有61名参与者注册，其中包括过去4年的23名参与者 月份。我们预计在当前资助期结束前招收85个科目。 (2023年4月30日)，并在延长期内完成招生。收盘时- 请拨出资金以完成试验计划中的招募工作，并 完成本项目批准的目标。节省了相关成本 通过实验室测试、程序和科目付款；这些节省的资金将用于支付 因此，没有为这些活动申请额外的资金。

Summary This application requests close-out funds to enable completion of the trial and accomplishment of the proposed aims of the project. This planned extension of the trial, discussed previously on several occasions during the past 2 years with the trial's DSMB and the program staff, was necessitated because of the nationwide suspension of clinical research activities in 2020 due to the onset of the COVID-19 pandemic. Even after the complete suspension of non-Covid clinical research activities was lifted, the subsequent ramp up of clinical research activities in 2020 and 2021 was substantially slower than in the pre-pandemic period due to the COVID-related restrictions and other reasons that are described in the Research Strategies section. These COVID-related constraints substantially slowed participant enrollment and delayed the completion of the trial. With the gradual lifting of these Covid-related restrictions during the past year, and a number of steps implemented by the study team that are described in the Research Strategies section, including the addition of a second trial site at the Brady Urology Center at the Johns Hopkin Medical Institutions; increased personnel effort for participant screening; and some DSMB-recommended revisions of eligibility criteria, the enrollment in the trial has increased substantially averaging 6 randomizations each month during the past several months. As described in the Research Strategies section, 61 participants had been enrolled as of December 31, 2022, including 23 in the past 4 months. We anticipate enrolling 85 subjects by the end of the current funding period (April 30, 2023) and completing the enrollment during the extension period. The close- out funds are requested for completing the planned recruitment in the trial and accomplishing the approved aims of this project. There was saving of costs associated with laboratory tests, procedures, and subject payments; these savings will be carried forward and no additional funds have been requested for these activities.