Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 20
- 主要终点
- Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up
研究概览
简要总结
To determine the effects of exercise therapy on molecular, radiologic, and pathologic nimbosus hallmarks versus usual care control in men on Active Surveillance for localized prostate cancer.
详细描述
The purpose of this study is to find out the effects of exercise therapy on indicators of prostate cancer in people with low-risk prostate cancer who are on active surveillance. The exercise therapy in this study will be regular home-based walking sessions on a treadmill, and that therapy will be assigned by an exercise physiologist (a medical professional who studies how exercise affects the human body). Some participants in this study will have the assigned exercise therapy, and some participants will participate in their usual exercise routines. Researchers will compare how the assigned exercise therapy and the usual exercise routines affect indicators of prostate cancer in participants. This study will not provide treatment for prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Men with histologically confirmed localized prostate cancer undergoing active surveillance.
- •Inactive, defined as not meeting the national exercise guidelines for cancer patients (<150 minutes/week of moderate or vigorous exercise)43 as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry (general physical activity screening assessment via smart watch).
- •Screening clearance by an MSK Exercise Physiologist (i.e., review of ECG)
- •BMI <40 kg/m^2
- •Cleared for exercise participation as per pre-screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+) (Appendix B)
排除标准
- •Enrollment in any other program that may alter the impact of exercise on tumor outcomes (e.g., weight loss program)
- •Any neoadjuvant anticancer treatment of any kind for prostate cancer in the last 5 years
- •Any history of systemic anticancer therapy in the last 15 years
- •Distant metastatic malignancy of any kind
- •Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
研究组 & 干预措施
Participants Assigned to Exercise Therapy
Participants with histologically confirmed localized prostate cancer undergoing active surveillance
干预措施: Exercise Therapy (Behavioral)
Participants Assigned to Usual Care
Participants with histologically confirmed localized prostate cancer undergoing active surveillance
结局指标
主要结局
Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up
时间窗: 6-12 months
The phenomenon of multiple independent prognostic features that moderately correlate with one another has been termed Nimbosus, "a gathering of storm clouds". The more Nimbosus hallmarks present in a tumor, the more aggressive it is likely to be, and the greater the chance that it will escape the prostate leading to nodal and distal metastatic spread. Nimbosus hallmarks provides a targetable set of biomarkers to test in a RCT of exercise therapy in localized prostate cancer. Molecular end points will be evaluated on FFPE tumor samples obtained from a total of two ultrasound-guided transrectal prostate biopsies performed at pretreatment (diagnostic biopsy) and post-intervention around month 6-12 (confirmatory biopsy), as per standard procedures.
次要结局
未报告次要终点