Nutrition and exercise interventions for prostate cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of personalized nutrition and exercise counseling in reducing obese frailty among prostate cancer survivors undergoing androgen deprivation therapy. Participants will receive tailored dietary plans and engage in a structured home-based exercise program over six months, including both aerobic and resistance training. The study aims to assess changes in myokine expression, body composition, muscle strength, and overall quality of life. Monthly educational meetings will support adherence to the interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Biopsy-confirmed prostate adenocarcinoma of any stage/grade
* Prescribed or already receiving continuous ADT for \< 5 years
* Hemoglobin \> 11 g/dL
* Creatinine \< 1.5 x upper limit of normal (ULN), AST or ALT \<2 x ULN within 6 months prior to enrollment
* Liver function tests \< 2 x ULN
* Able to walk unassisted at least 100 meters (200 steps) or ECOG \<= 1
* No contraindications to any aspect of participation, including aerobic exercise
* Participant must be able to read, write, and understand the English language and be able to provide written consent
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias
* Limiting orthopedic, musculoskeletal or psychological conditions (clinician discretion)
* Overall medical frailty (clinician discretion)
* Any condition contraindicating additional blood collection beyond standard of care
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Where it's running

• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting

Study contacts

• Principal investigator: Ellis Levine, MD — Roswell Park Cancer Institute
• Study coordinator: Ellis Levine, MD
• Email: Ellis.Levine@Roswellpark.org
• Phone: 716-845-3159

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.