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?

Cedars-Sinai Cancer at SOCC : Ana Martin

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

Edwin Posadas, Gillian Gresham, Jun Gong, Lauren J Amaral, Pao-Hwa Lin, 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