A Study to Evaluate the Feasibility of Daily, Long-Term, Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy

Overview

About this study

The purpose of this study is to determine whether men treated for localized prostate cancer adhere to a long-term (months-years) daily intermittent fasting regimen, and 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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, GnRH agonist/antagonist).

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Karnes, M.D.

Open for enrollment

Contact information:

Vidhu Joshi B.S.

(507)538-5772

Joshi.Vidhu@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20472026

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