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

NCT04288336 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2022-07-11

No results posted yet for this study

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.

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

Interventions

OTHER

Food Diary

Ancillary studies

OTHER

Preventative Dietary Intervention

Follow intermittent fasting

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Robert J Karnes · Mayo Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-08
Primary Completion
2022-03-25
Completion
2022-03-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288336 on ClinicalTrials.gov