Daily, Long-Term Intermittent Fasting for the Prevention of PSA-Recurrence in Patients With Localized Prostate Cancer After Radical Prostatectomy

Mayo Clinic

Status and phase

Withdrawn

Early Phase 1

Conditions

Stage IIIC Prostate Cancer AJCC v8

Stage I Prostate Cancer AJCC v8

Stage IIA Prostate Cancer AJCC v8

Stage IIC Prostate Cancer AJCC v8

Stage IIIB Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage IIIA Prostate Cancer AJCC v8

Stage IIB Prostate Cancer AJCC v8

Treatments

Other: Preventative Dietary Intervention

Other: Food Diary

Other: Questionnaire Administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04288336

P30CA015083 (U.S. NIH Grant/Contract)

MC2052

19-006675 (Other Identifier)

NCI-2020-00832 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)