A Prospective Pilot Study Evaluating the Feasibility of Daily, Long-Term Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy for Localized, High-Risk Prostate Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- Adherence to the daily intermittent fasting regimen
研究概览
简要总结
This early phase I trial studies the feasibility of a daily, long-term intermittent fasting routine in preventing or delaying a rise in prostate specific antigen (PSA) levels in patients with prostate cancer that has not spread to other parts of the body (localized) and who have undergone radical prostatectomy. PSA is a protein produced by both normal and cancer cells. Following a daily fasting routine after treatment for prostate cancer may lower the risk of patients' PSA level rising above 0.4 ng/mL, which is also called PSA-recurrence. A PSA-recurrence can sometimes mean that the disease has returned and/or progressed.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether men treated for localized prostate cancer adhere to a long-term (months-years) daily intermittent fasting regimen.
II. To measure the levels of metabolic and prostate-cancer derived microparticles in the serum of men that practice a daily intermittent fasting regimen after treatment for localized, high-risk prostate cancer.
OUTLINE:
Beginning when patients' PSA is detectable up to 24 months after surgery, patients follow a daily intermittent fasting routine consisting of restricting the daily eating period to 8 hours (e.g. between 1PM-9PM) followed by 16 hours of prolonged nightly fasting for up to 1 year or until secondary therapy commences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Biopsy-proven histological diagnosis of localized prostate cancer (pT2 or specimen confined pT3)
- •Having undergone radical prostatectomy (open or laparoscopic) with bilateral pelvic lymph node dissection
- •Negative surgical margins on final specimen
- •Men that decline adjuvant therapy
- •Detectable serum PSA of 0.1 ng/mL or >
- •24 months or less since radical prostatectomy at time of study screening
排除标准
- •Unable or unwilling to provide informed consent
- •Treated prior to surgery with any form of hormone, antiandrogen, or androgen deprivation therapy
- •Treated prior to surgery with any form of chemotherapy or radiotherapy
- •Medical conditions/history that precludes subjects from following a fasting regimen, including but not limited to:
- •Diabetes mellitus
- •On hormone therapy (Casodex, gonadotrophin releasing hormone [GnRH] agonist/antagonist)
结局指标
主要结局
Adherence to the daily intermittent fasting regimen
时间窗: Up to 1 year
Will be assessed via the phone surveys conducted at each remote follow up visit, as well as through analysis of the subjects' daily journals that will be sent back to the study team at the end of the study period.
次要结局
- Prostate specific antigen (PSA) kinetics and/or doubling time(Up to 1 year)