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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-08

Study Completion Date

2022-03-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Food Diary

Intervention Type OTHER

Ancillary studies

Preventative Dietary Intervention

Intervention Type OTHER

Follow intermittent fasting

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Food Diary

Ancillary studies

Intervention Type OTHER

Preventative Dietary Intervention

Follow intermittent fasting

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No