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

Sponsor
Mayo Clinic (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04288336
Collaborator
National Cancer Institute (NCI) (NIH)
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Study Details

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:
  1. To determine whether men treated for localized prostate cancer adhere to a long-term (months-years) daily intermittent fasting regimen.

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 8, 2020
Actual Primary Completion Date :
Mar 25, 2022
Actual Study Completion Date :
Mar 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prevention (intermittent fasting)

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.

Other: Food Diary
Ancillary studies

Other: Preventative Dietary Intervention
Follow intermittent fasting

Other: Questionnaire Administration
Ancillary studies

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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 >.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Robert J Karnes, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04288336
Other Study ID Numbers:
  • 19-006675
  • NCI-2020-00832
  • MC2052
  • 19-006675
  • P30CA015083
First Posted:
Feb 28, 2020
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2022