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

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Trial Identification

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

Official Title: 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

Study ID: NCT04288336

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Mayo Clinic, Rochester, Minnesota, United States

Contact Details

Name: Robert J Karnes

Affiliation: Mayo Clinic

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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