ASSESSing the Impact of Decipher on Practice Decision Making in Prostate Cancer After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in treatment recommendation
研究概览
简要总结
This prospectively designed retrospective clinical utility study will evaluate urologists' treatment recommendations before and after reviewing Decipher results for selected patient cases.
详细描述
The clinical utility of Decipher will be evaluated at two time-points:
- Post RP - within 6 months after surgery
- PSA rise - defined as PSA detectable and rising on 2 or more subsequent determinations
Patient cases will be retrospectively selected from at least 5 sites. Participating urologists at each site will be asked to each identify a minimum of 10 to a maximum of 50 suitable cases retrospectively. The resulting cases will then be de-identified, aggregated and evenly randomly distributed among the participating urologists via a secure on-line survey platform . All study participants (ie: urologists) will be masked to the original actual treatment decision and patient outcome.
The design of this study is such that any participating urologist may or may not review a patient originating from their own clinical practice, but will not review a case they themselves identified. Patient cases will be de-identified and randomized amongst participating urologists . By the retrospective nature of this study, cases may be several years post-RP. It is not expected that that participation in this study will have any impact on actual clinical management of patients.
Participants will be asked to complete two web-based electronic Case Report Questionnaires (eCRQ):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient cases eligible for this study were treated with radical prostatectomy and have one or more adverse features present as defined by AUA and NCCN guidelines:
- •Pathological T3 stage of disease (i.e., ECE or SVI)
- •Positive surgical margins, or
- •Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations
排除标准
- •Metastatic Disease (M+) prior to surgery
- •Failure of PSA to nadir after surgery
- •Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
- •Received any adjuvant chemotherapy
- •Required patient clinical data (Section 5.3) is not available for evaluation of eligibility criteria
- •Lack of documented treatment or management recommendation on file
- •Tissue specimen is inadequate for sampling and analysis
结局指标
主要结局
Change in treatment recommendation
时间窗: 1.5 years
Change in treatment recommendation from pre- to post-Decipher report, defined as any change in treatment recommendation. Specifically this will be defined as (pre- to post-): RT to ADT RT to ADT \& RT RT to Observation ADT to RT ADT to ADT \& RT ADT to Observation ADT \& RT to RT ADT \& RT to ADT ADT \& RT to Observation Observation to RT Observation to ADT Observation to RT \& ADT
次要结局
- Specific change in treatment recommendation(1.5 years)
- Changes in intensity of treatment(1.5 years)
- Confidence in treatment recommendation(1.5 years)
- Changes in the decision conflict scale(1.5 years)
- Utility of Decipher(1.5 years)
- Change in treatment recommendation compared to baseline(1.5 years)