A Study to Evaluate the Feasibility of Daily, Long-Term, Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-006675
NCT ID: NCT04288336
Sponsor Protocol Number: 19-006675
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:
- 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
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Supplemental Study Information
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