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

Primary Purpose

Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Food Diary
Preventative Dietary Intervention
Questionnaire Administration
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stage I Prostate Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (intermittent fasting)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 >.

Full Information

First Posted
February 26, 2020
Last Updated
July 6, 2022
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04288336
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 Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No patient accrual
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevention (intermittent fasting)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Food Diary
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Preventative Dietary Intervention
Intervention Description
Follow intermittent fasting
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Adherence to the daily intermittent fasting regimen
Description
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 Outcome Measure Information:
Title
Prostate specific antigen (PSA) kinetics and/or doubling time
Description
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 >.
Time Frame
Up to 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Karnes
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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