This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.
Be willing and able to provide written informed consent for the trial.
Be male at birth and least 18 years of age on day of signing informed consent.
Have measurable prostate cancer disease and be eligible for androgen deprivation therapy.
Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Has an ECOG performance of 2 or higher.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the beginning of the treatment.
Has a known additional malignancy that is progressing or requires active treatment.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Single group
Intermittent Fasting
Other interventionDietary intervention
Enrollment rate
Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy
Drop-out rate
Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy
Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.
Clinical efficacy of the combination of intermittent fasting with or without a plant-enriched diet plus androgen deprivation therapy
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Safety, tolerability and reduction of common toxicities of the combination of intermittent fasting and the option of a plant-enriched diet intervention as compared to historical data.
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