Status:
WITHDRAWN
Daily, Long-Term Intermittent Fasting for the Prevention of PSA-Recurrence in Patients With Localized Prostate Cancer After Radical Prostatectomy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04288336
Start Date
January 8 2020
End Date
March 25 2022
Last Update
July 11 2022
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905