Daily, Long-Term Intermittent Fasting for the Prevention... | NCT04288336

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

NCT04288336

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Jul 11, 2022Actual

Enrollment

0Actual

Phase

Early Phase 1

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

Interventions

Food Diary
Preventative Dietary Intervention
Questionnaire Administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2020-00832	Registry Identifier	CTRP (Clinical Trial Reporting Program)
MC2052
19-006675	Other Identifier	Mayo Clinic
P30CA015083	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patient accrual

Expanded Access Info

Start Date

Jan 8, 2020Actual

Primary Completion Date

Mar 25, 2022Actual

Completion Date

Mar 25, 2022Actual

First Submitted Date

Feb 26, 2020

First Submission Date that Met QC Criteria

Feb 26, 2020

First Posted Date

Feb 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2022

Last Update Posted Date

Jul 11, 2022Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prevention (intermittent fasting)	Experimental	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.	Other: Food Diary Other: Preventative Dietary Intervention Other: Questionnaire Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Food Diary	Other	Ancillary studies	Prevention (intermittent fasting)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D011996	Records
D009934	Organization and Administration
D006298	Health Services Administration