NCT01763944已完成不适用
A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 6
- 主要终点
- PSA doubling time (change in PSA over time)
研究概览
简要总结
No treatments have been shown to slow prostate cancer progression after radical prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (<20 grams carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome is PSA doubling time.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Received prior radical prostatectomy or definitive local radiation for prostate cancer (either external beam radiation, brachytherapy, or combination)
- •PSA within the past 3 months is between 0.4 and 20 if prior radical prostatectomy, or between 3 and 20 ng/ml if prior radiation therapy.
- •PSA doubling time (PSADT) >3 months and <36 months
- •Calculated based at least 2 values (at least 0.2) in the prior 2 years with the first and last PSA separated by at least 3 months
- •Use all values in the last 2 years to calculate PSADT
- •PSADT calculated while NOT on androgen deprivation therapy (ADT).
- •If prior ADT use, then documented either A) normal testosterone or B) a testosterone within 50 points of normal and stable (defined as a second testosterone at least 6 weeks later that is equal or lower than the first testosterone) is required before starting to calculate PSADT.
- •BMI >=24 kg/m2
- •Willing to be randomized to a no-diet control or a low-carbohydrate diet
- •Reads, writes, and understands English
排除标准
- •Anticipate needing secondary prostate cancer therapy within the next 6 months (i.e. radiation, or hormonal therapy)
- •Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
- •Currently on therapy aimed at lowering testosterone levels (includes gonadotropin-releasing hormone (GnRH) agonist/antagonist, prior bilateral orchiectomy, oral anti-androgens, or 5-alpha reductase inhibitors). Testosterone replacement is allowed but treatment should be stable during the entire study.
- •Known distant metastatic disease
- •Already consuming a carbohydrate-restricted or vegetarian diet
- •Unable or unwilling to adhere to a carbohydrate-restricted dietary intervention
- •Weight loss >5% of body weight in the last 6 months
- •Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
研究组 & 干预措施
Low carbohydrate, lifestyle counseling
Active Comparator
The Low carbohydrate arm will receive counseling to follow a carbohydrate restriction diet (<20 grams per day) for 6 months.
干预措施: Low carbohydrate diet (Behavioral)
Control
No Intervention
The control arm will receive no dietary intervention.
结局指标
主要结局
PSA doubling time (change in PSA over time)
时间窗: Baseline, 3 and 6 months
PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.
次要结局
未报告次要终点
研究者
研究点 (6)
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