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

Early Phase 1WithdrawnNCT04288336

Mayo Clinic

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Conditions

Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Adherence to the daily intermittent fasting regimen

Will be assessed via the phone surveys conducted at each remote follow up visit, as well as through analysis of the subjects' daily journals that will be sent back to the study team at the end of the study period.

Time frame: Up to 1 year

Secondary Outcomes

Prostate specific antigen (PSA) kinetics and/or doubling time

Will assess the PSA kinetics and/or doubling time as it relates to historical patients whom have also undergone PSA surveillance with postoperative PSA detection 0.1 or \>.