Stage III Prostate Cancer AJCC v8 Clinical Trial
Official title:
A Prospective Pilot Study Evaluating the Feasibility of Daily, Long-Term Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy for Localized, High-Risk Prostate Cancer
Verified date | July 2022 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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) |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
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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