NCT05303558已完成不适用
Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
Johnson & Johnson International (Singapore) Pte. Ltd.9 个研究点 分布在 3 个国家目标入组 221 人开始时间: 2022年8月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 9
- 主要终点
- Yearly Conditional Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Probability
研究概览
简要总结
The purpose of this study is to evaluate the yearly conditional prostate-specific antigen (PSA) progression-free survival (PFS) probabilities in high-risk localized prostate cancer (HR LPC) participants following radical prostatectomy (RP) and perioperative hormonal therapies (that is, hormonal treatment before RP and / or after RP) over 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have histologically confirmed adenocarcinoma of the prostate
- •Participants newly diagnosed between 1 January 2015 to 30 June 2017 (both dates inclusive)
- •Participants fulfil high-risk localized prostate cancer defined by national comprehensive cancer network (NCCN) prostate cancer guideline (2020 version 1) a. T3a or; b. Grade group 4 or Grade group 5 or; c. Prostate specific antigen (PSA) greater than (>) 20 nanograms per milliliter (ng/mL)
- •Participants must have received radical prostatectomy (RP) between 1 January 2015 and 30 June 2017
- •Participants must have received at least one perioperative hormonal therapy pattern as listed below:
- •greater than or equal to (>=) 3 months neoadjuvant hormonal therapy, duration between date of last dose and date of RP should be less than or equal to (<=) 2 months; and/or
- •>= 6 months adjuvant hormonal therapy, first dose started within 6 months of RP surgery
排除标准
- •Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis
结局指标
主要结局
Yearly Conditional Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Probability
时间窗: Up to 5 years
PSA PFS probability is defined as probability of being PSA progression free given that participant has yet to experience PSA progression or death from any cause. PSA progression is defined as per the prostate cancer working group 2 (PCWG2) consensus.
次要结局
- Time from Diagnosis of LPC to Radical Prostatectomy (RP)(Up to 2.5 years)
- Hormonal Therapy Duration(Up to 7.5 years)
- Number of Participants who Received Treatments Provided with RP and Following RP(Up to 7.5 years)
- Yearly Conditional Local or Distant Radiographic PFS Probability(Up to 5 years)
- Localized Prostate Cancer (LPC) Stage at Diagnosis(Up to 2.5 years)
研究者
研究点 (9)
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