Abstract：
BACKGROUND: Recently approved treatments and updates to genetic testing recommendations for prostate cancer have created a need for correlated analyses of patient outcomes data via germline genetic mutation status. Genetic registries address these gaps by identifying candidates for recently approved targeted treatments, expanding clinical trial data examining specific gene mutations, and understanding effects of targeted treatments in the real-world setting.
METHODS: The PROMISE Registry is a 20-year (5-year recruitment, 15-year follow-up), US-wide, prospective genetic registry for prostate cancer patients. Five thousand patients will be screened through an online at-home germline testing to identify and enroll 500 patients with germline mutations, including: pathogenic or likely pathogenic variants and variants of uncertain significance in genes of interest. Patients will be followed for 15 years and clinical data with real time patient reported outcomes will be collected. Eligible patients will enter long-term follow-up (6-month PRO surveys and medical record retrieval). As a virtual study with patient self-enrollment, the PROMISE Registry may fill gaps in genetics services in underserved areas and for patients within sufficient insurance coverage.
RESULTS: The PROMISE Registry opened in May 2021. 2114 patients have enrolled to date across 48 US states and 23 recruiting sites. 202 patients have met criteria for long-term follow-up. PROMISE is on target with the study\'s goal of 5000 patients screened and 500 patients eligible for long-term follow-up by 2026.
CONCLUSIONS: The PROMISE Registry is a novel, prospective, germline registry that will collect long-term patient outcomes data to address current gaps in understanding resulting from recently FDA-approved treatments and updates to genetic testing recommendations for prostate cancer. Through inclusion of a broad nationwide sample, including underserved patients and those unaffiliated with major academic centers, the PROMISE Registry aims to provide access to germline genetic testing and to collect data to understand disease characteristics and treatment responses across the disease spectrum for prostate cancer with rare germline genetic variants.
METHODS: The PROMISE Registry is a 20-year (5-year recruitment, 15-year follow-up), US-wide, prospective genetic registry for prostate cancer patients. Five thousand patients will be screened through an online at-home germline testing to identify and enroll 500 patients with germline mutations, including: pathogenic or likely pathogenic variants and variants of uncertain significance in genes of interest. Patients will be followed for 15 years and clinical data with real time patient reported outcomes will be collected. Eligible patients will enter long-term follow-up (6-month PRO surveys and medical record retrieval). As a virtual study with patient self-enrollment, the PROMISE Registry may fill gaps in genetics services in underserved areas and for patients within sufficient insurance coverage.
RESULTS: The PROMISE Registry opened in May 2021. 2114 patients have enrolled to date across 48 US states and 23 recruiting sites. 202 patients have met criteria for long-term follow-up. PROMISE is on target with the study\'s goal of 5000 patients screened and 500 patients eligible for long-term follow-up by 2026.
CONCLUSIONS: The PROMISE Registry is a novel, prospective, germline registry that will collect long-term patient outcomes data to address current gaps in understanding resulting from recently FDA-approved treatments and updates to genetic testing recommendations for prostate cancer. Through inclusion of a broad nationwide sample, including underserved patients and those unaffiliated with major academic centers, the PROMISE Registry aims to provide access to germline genetic testing and to collect data to understand disease characteristics and treatment responses across the disease spectrum for prostate cancer with rare germline genetic variants.
摘要：
背景：最近批准的前列腺癌治疗和基因检测建议的更新已经产生了通过种系基因突变状态对患者结果数据进行相关分析的需求。遗传登记处通过确定最近批准的靶向治疗的候选者来解决这些差距。扩大检查特定基因突变的临床试验数据，并了解在现实世界中靶向治疗的效果。
方法：PROMISERegistry是一个20年（5年招聘，15年随访)，在美国范围内，前列腺癌患者的前瞻性遗传登记。将通过在线家庭种系测试对五千名患者进行筛查，以识别并招募500名具有种系突变的患者，包括:目的基因中致病或可能致病的变异和不确定意义的变异。将随访患者15年，并收集实时患者报告结果的临床数据。符合条件的患者将进入长期随访（6个月的PRO调查和病历检索）。作为一项患者自我登记的虚拟研究，PROMISE登记处可以填补服务不足地区和足够保险范围内的患者的遗传学服务空白。
结果：PROMISERegistry于2021年5月开放。迄今为止，已有2114名患者在美国48个州和23个招募地点注册。202名患者符合长期随访标准。该研究的目标是到2026年筛选5000名患者和500名符合长期随访条件的患者。
结论：PROMISERegistry是一部小说，prospective,种系注册，将收集长期患者结果数据，以解决当前由于FDA最近批准的治疗和前列腺癌基因检测建议的更新而导致的理解差距。通过纳入广泛的全国样本，包括服务不足的患者和与主要学术中心无关的患者，PROMISERegistry旨在提供种系基因检测的访问权限,并收集数据,以了解具有罕见种系遗传变异的前列腺癌的疾病特征和整个疾病谱的治疗反应.
方法：PROMISERegistry是一个20年（5年招聘，15年随访)，在美国范围内，前列腺癌患者的前瞻性遗传登记。将通过在线家庭种系测试对五千名患者进行筛查，以识别并招募500名具有种系突变的患者，包括:目的基因中致病或可能致病的变异和不确定意义的变异。将随访患者15年，并收集实时患者报告结果的临床数据。符合条件的患者将进入长期随访（6个月的PRO调查和病历检索）。作为一项患者自我登记的虚拟研究，PROMISE登记处可以填补服务不足地区和足够保险范围内的患者的遗传学服务空白。
结果：PROMISERegistry于2021年5月开放。迄今为止，已有2114名患者在美国48个州和23个招募地点注册。202名患者符合长期随访标准。该研究的目标是到2026年筛选5000名患者和500名符合长期随访条件的患者。
结论：PROMISERegistry是一部小说，prospective,种系注册，将收集长期患者结果数据，以解决当前由于FDA最近批准的治疗和前列腺癌基因检测建议的更新而导致的理解差距。通过纳入广泛的全国样本，包括服务不足的患者和与主要学术中心无关的患者，PROMISERegistry旨在提供种系基因检测的访问权限,并收集数据,以了解具有罕见种系遗传变异的前列腺癌的疾病特征和整个疾病谱的治疗反应.
