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
Food Diary
+ Preventative Dietary Intervention
+ Questionnaire Administration
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Prevention Study
Summary
Study start date: January 8, 2020
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Biopsy-proven histological diagnosis of localized prostate cancer (pT2 or specimen confined pT3) * Having undergone radical prostatectomy (open or laparoscopic) with bilateral pelvic lymph node dissection * Negative surgical margins on final specimen * Men that decline adjuvant therapy * Detectable serum PSA of 0.1 ng/mL or \> * 24 months or less since radical prostatectomy at time of study screening Exclusion Criteria: * Unable or unwilling to provide informed consent * Treated prior to surgery with any form of hormone, antiandrogen, or androgen deprivation therapy * Treated prior to surgery with any form of chemotherapy or radiotherapy * Medical conditions/history that precludes subjects from following a fasting regimen, including but not limited to: * Diabetes mellitus * On hormone therapy (Casodex, gonadotrophin releasing hormone \[GnRH\] agonist/antagonist)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location