For the first time ever — as far as anyone seems to be aware — a major cancer center will soon start to implement a controlled, randomized clinical trial of calorie restriction as a treatment for cancer. And they will be doing this trial in men with progressive prostate cancer.
According to the trial information on the ClinicalTrials.gov web site, the clinical research team at Duke University intend to implement a pilot-scale, Phase II study in which a total of 60 men with a rising PSA after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (< 20 g carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome of the trial will be PSA doubling time.
A detailed discussion of the background to calorie restriction as a form of treatment for cancer is given in an article (“Calorie restriction to treat cancer: the time is n0w“) on the Medscape Oncology web site. Over the years we have accumulated significant data on this topic from animal studies and from clinical series of patients, but there has never before been an actual, randomized, controlled clinical trial.
The “New” Prostate Cancer InfoLink would strongly encourage eligible patients to enroll in this trial — particularly those who live in the Raleigh-Durham area of North Carolina. The key eligibility criteria are listed in the trial information link given above. We see this study as a key trial that could significantly impact future thinking about the management of progressive prostate cancer.