Comprehensive Monitoring of Men With Prostate Cancer Cared for by "Active Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To estimate the 5-year disease progression rate of patients with low or very low-risk prostate cancer who choose to undergo active surveillance with remote monitoring
研究概览
简要总结
Prostate cancer is the most commonly diagnosed cancer in men. However, there is a wide range in prognosis determined by a host of factors. This study will evaluate the feasibility of guiding therapeutic intervention electronically facilitated symptom and disease monitoring in patients being followed on Active Surveillance. Additionally, we will develop a tissue and data resource to support discovery and hypothesis generation to evaluate germline and/or somatic alterations in relation to cancer-specific and overall outcomes..
详细描述
Primary objectives:
1. Monitor cancer-specific outcomes of men who meet consensus criteria for active surveillance under one of three categories: 1) low or very low-risk prostate cancer, 2) intermediate risk with patient consent, or 3) severe medical comorbidities and high-risk localized prostate cancer or patient desire, despite recommendation
Secondary objectives:
- Screen for a relationship between cancer-specific and clinical outcomes related to selected comorbidities.
- Determine the feasibility of electronically facilitated symptoms and disease monitoring to guide therapeutic intervention and prompt therapeutic course correction.
- Develop a tissue and data resource to support discovery and hypothesis generation focused on germline alterations, somatic alterations, and/or the interaction between the two in determining cancer-specific and overall outcomes
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients will have histologic diagnosis of adenocarcinoma of the prostate within 24 months of study entry.
- •Patient must meet at least one of the following clinical indications for AS: National Comprehensive Cancer Network (NCCN) very low risk or low risk prostate cancer meeting consensus guidelines for AS; NCCN intermediate-risk prostate cancer requesting AS (per patient and clinician shared decision making); or have severe medical comorbidities (defined as CCI estimated 10-year survival < 50% and agreed by treating clinician) with high- or very high-risk localized prostate cancer.
- •Patients must agree to comply with the surveillance schedule.
- •Patients must be over 18 years of age
- •Written informed consent
- •Patients must be fluent in the English language to participate in the patient report outcome and symptoms monitoring portion of the trial.
排除标准
- •Patients are ineligible if they choose not to share their medical data for research purposes.
- •Prior radiation therapy for treatment of the primary tumor.
- •Planned concomitant hormonal therapy, chemotherapy, or radiation therapy while on protocol
研究组 & 干预措施
Cohort-1
Participants with localized very low- or low-risk prostate cancer meeting consensus criteria for active surveillance
干预措施: Active Surveillance (Other)
Cohort-2
Participants with NCCN intermediate-risk localized prostate cancer requesting active surveillance (per patient and clinician shared decision making);
干预措施: Active Surveillance (Other)
Cohort-3
Participants with severe medical comorbidities (defined as CCI estimated 10-year survival < 50% and agreed by treating clinician) and high- or very high-risk group localized prostate cancer.
Clinical trial investigators and staff will make every effort to integrate study visits with the subjects' clinic visits during participation.
干预措施: Active Surveillance (Other)
结局指标
主要结局
To estimate the 5-year disease progression rate of patients with low or very low-risk prostate cancer who choose to undergo active surveillance with remote monitoring
时间窗: through study completion; an average of 1 year.
次要结局
未报告次要终点