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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04288336
Other study ID # 19-006675
Secondary ID NCI-2020-00832MC
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date January 8, 2020
Est. completion date March 25, 2022

Study information

Verified date July 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 25, 2022
Est. primary completion date March 25, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Food Diary
Ancillary studies
Preventative Dietary Intervention
Follow intermittent fasting
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Prostate specific antigen (PSA) kinetics and/or doubling time 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 >. Up to 1 year
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