Improving Quality of Life of Prostate Cancer Survivors with Androgen Deficiency

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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.