Clinical trial NCT04288336: Daily, Long-Term Intermittent Fasting for the Prevention of PSA-Recurrence in Patients With Localized Prostate Cancer After Radical Prostatectomy
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-28
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Adherence to the daily intermittent fasting regimen
timeFrame: Up to 1 year
Secondary outcomes:
measure: Prostate specific antigen (PSA) kinetics and/or doubling time
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert J Karnes
role: PRINCIPAL_INVESTIGATOR
References: