Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes

What is the Purpose of this Study?

The purpose of this study is to evaluate how a fasting-mimicking diet versus a usual diet influences cancer treatment of metastatic castrate-sensitive prostate adenocarcinoma. The fasting-mimicking diet is a 5-day program of plant-based products that the participant will consume to place the body into a fasting state. Examples of food products include soups, broths, energy bars, energy drinks, cracker snacks, herbal teas, and supplements. Preclinical work (research before studies with humans) has shown that a fasting diet can positively change the way the body responds to cancer treatment. In this study, researchers also aim to learn whether biomarkers change with a fasting diet. A biomarker is a biological molecule found in blood, other body fluids or tissues that may be a sign of a condition or disease and can be used to predict response to treatment. Participants will be randomly assigned to 1 of 2 groups. Group 1 will eat their usual diet, and Group 2 will eat a fasting-mimicking diet for 5 days in a row, every month for 6 months. Participants will also receive a Fitbit to be worn continuously during the study and will be asked to complete surveys and blood draws.


Eligibility

  • * Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan)
  • * Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy
  • * Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian.
  • * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
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Where can I participate?

  • CS Cancer at Cedars-Sinai Medical Center : Ana Martin
  • CS Cancer at The Angeles Clinic and Research Institute : Ana Martin
  • City of Hope (Study Affiliate)
  • Duke University (Study Affiliate)
  • Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer


More about this Clinical Trial

What is the full name of this clinical trial?

IIT2023-02-FREEDLAND-FAST-PRO: Intermittent Fasting using a Fasting-Mimetic Diet to Improve Prostate Cancer Control and Metabolic Outcomes

Study Details
Disease Type/Condition

Lifestyle, Prostate cancer

Principal Investigator

Freedland, Stephen

Co-Investigators

Andrew Horodner, Cathie T Chung, David Chan, Edwin Posadas, Gillian Gresham, Hugo Hool, Inderjit Mehmi, Iryna Singh, Jun Gong, Justin Moyers, Justin Wayne Tiulim, Kristopher Wentzel, Lauren J Amaral, Navid Hafez, Omid Hamid, Pao-Hwa Lin, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey, Vi K. Chiu, You Sungyong

Age Group

Adult

Phase

II

IRB Number

STUDY00002714

ClinicalTrials.gov ID

NCT05832086

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Ana Martin

Email
ana.martin@cshs.org
Study Detail
Disease Type/Condition

Lifestyle, Prostate cancer

Principal Investigator

Freedland, Stephen

Age Group

Adult

Phase

II

IRB Number

IIT2023-02-FREEDLAND-FAST-PRO

ClinicalTrials.gov ID

NCT05832086

Key Eligibility
ClinicalTrials.gov

Contact
Name

Ana Martin

Email
ana.martin@cshs.org