Daily, Long-Term Intermittent Fasting for the Prevention of PSA-Recurrence in Patients With Localized Prostate Cancer After Radical Prostatectomy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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Early Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
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To determine whether men treated for localized prostate cancer adhere to a long-term (months-years) daily intermittent fasting regimen.
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Prevention (intermittent fasting) 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 Diary
Ancillary studies
Other: Preventative Dietary Intervention
Follow intermittent fasting
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Adherence to the daily intermittent fasting regimen [Up to 1 year]
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.
Secondary Outcome Measures
- Prostate specific antigen (PSA) kinetics and/or doubling time [Up to 1 year]
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 >.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Biopsy-proven histological diagnosis of localized prostate cancer (pT2 or specimen confined pT3)
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Having undergone radical prostatectomy (open or laparoscopic) with bilateral pelvic lymph node dissection
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Negative surgical margins on final specimen
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Men that decline adjuvant therapy
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Detectable serum PSA of 0.1 ng/mL or >
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24 months or less since radical prostatectomy at time of study screening
Exclusion Criteria:
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Unable or unwilling to provide informed consent
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Treated prior to surgery with any form of hormone, antiandrogen, or androgen deprivation therapy
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Treated prior to surgery with any form of chemotherapy or radiotherapy
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Medical conditions/history that precludes subjects from following a fasting regimen, including but not limited to:
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Diabetes mellitus
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On hormone therapy (Casodex, gonadotrophin releasing hormone [GnRH] agonist/antagonist)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Robert J Karnes, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19-006675
- NCI-2020-00832
- MC2052
- 19-006675
- P30CA015083