NCT04288336

Daily, Long-Term Intermittent Fasting for the Prevention of PSA-Recurrence in Patients With Localized Prostate Cancer After Radical Prostatectomy

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage IIA Prostate Cancer AJCC v8
• Stage IIB Prostate Cancer AJCC v8
• Stage IIC Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IIIA Prostate Cancer AJCC v8
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Food Diary	Ancillary studies
OTHER	Preventative Dietary Intervention	Follow intermittent fasting
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-01-08
• Primary completion: 2022-03-25
• Completion: 2022-03-25
• First posted: 2020-02-28
• Last updated: 2022-07-11

Locations

1 site across 1 country: United States