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

Early Phase 1

Withdrawn

• Conditions: Stage IIB Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage I Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8
• Interventions: Other: Food Diary; Other: Preventative Dietary Intervention; Other: Questionnaire Administration

• Registration Number: NCT04288336
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2020-01-08
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Primary Completion: 2022-03-25
• Study Completion: 2022-03-25
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention (intermittent fasting)	Food Diary	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.
Prevention (intermittent fasting)	Preventative Dietary Intervention	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.
Prevention (intermittent fasting)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Adherence to the daily intermittent fasting regimen	Up to 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Prostate specific antigen (PSA) kinetics and/or doubling time	Up to 1 year	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 \>.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States