NCT04288336

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

2.2 years

First QC Date

February 26, 2020

Last Update Submit

July 6, 2022

Conditions

Stage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage IIA Prostate Cancer AJCC v8Stage IIB Prostate Cancer AJCC v8Stage IIC Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8Stage IIIB Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 1 year

Secondary Outcomes (1)

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

    Up to 1 year

Study Arms (1)

Prevention (intermittent fasting)

EXPERIMENTAL

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 DiaryOther: Preventative Dietary InterventionOther: Questionnaire Administration

Interventions

Food DiaryOTHER

Ancillary studies

Prevention (intermittent fasting)
Preventative Dietary InterventionOTHER

Follow intermittent fasting

Prevention (intermittent fasting)
Questionnaire AdministrationOTHER

Ancillary studies

Prevention (intermittent fasting)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \>
  • months or less since radical prostatectomy at time of study screening

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diet Records

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RecordsOrganization and AdministrationHealth Services Administration

Study Officials

  • Robert J Karnes

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2020

First Posted

February 28, 2020

Study Start

January 8, 2020

Primary Completion

March 25, 2022

Study Completion

March 25, 2022

Last Updated

July 11, 2022

Record last verified: 2022-07

Locations

US(1)