Clinical Trials /

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

NCT04288336

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 19-006675
  • SECONDARY ID: NCI-2020-00832
  • SECONDARY ID: MC2052
  • SECONDARY ID: 19-006675
  • SECONDARY ID: P30CA015083
  • NCT ID: NCT04288336

Conditions

  • 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

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Prevention (intermittent fasting)ExperimentalBeginning 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.

    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)
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Adherence to the daily intermittent fasting regimen
    Time Frame:Up to 1 year
    Safety Issue:
    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.

    Secondary Outcome Measures

    Measure:Prostate specific antigen (PSA) kinetics and/or doubling time
    Time Frame:Up to 1 year
    Safety Issue:
    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 >.

    Details

    Phase:Early Phase 1
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Mayo Clinic

    Last Updated

    March 16, 2020