Nutrition and Exercise for Prostate Cancer Survivors on ADT

This study is looking at how nutrition and exercise programs can help prostate cancer survivors who are receiving androgen deprivation therapy (ADT). ADT can sometimes lead to weight gain and frailty. This study will give you an individualized diet plan and exercise program for six months. Researchers want to see if these interventions can improve your body composition (like muscle and fat) and overall well-being. They will also look at how these programs affect your muscle strength, energy levels, and quality of life. This study is for men aged 18 and older with prostate cancer who are currently on ADT or have been on it for less than five years.

Study design
This is an interventional study planning to enroll 50 participants. It will assess the effects of individualized nutrition and exercise counseling.
What's involved
You would receive an individualized diet plan for 6 months, attend educational meetings, and complete an exercise program. You would also have quality-of-life assessments and surveys.
Compensation
Not stated in the trial record.
Follow-up
Changes in body composition will be measured up to 6 months.

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NCT03880422

Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer

Recruiting
NAAges 18+InterventionalSupportive care
Roswell Park Cancer Institute
~50 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:Dietary InterventionEducational InterventionExercise InterventionQuality-of-Life AssessmentSurvey Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in body composition
Measured over Baseline up to 6 months
Cancer Survivor
Obesity
Overweight
Prostate Adenocarcinoma
Stage A Prostate Cancer
Stage B Prostate Cancer
Stage C Prostate Cancer
Stage D Prostate Cancer
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage IIC Prostate Cancer
Stage III Prostate Cancer
Stage IIIA Prostate Cancer
Stage IIIB Prostate Cancer
Stage IIIC Prostate Cancer
Stage IV Prostate Cancer
Stage IVA Prostate Cancer
Stage IVB Prostate Cancer
1 sites across 1 states
New York1
  • Ellis Levine, MD · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Changes in body compositionBaseline up to 6 months

    Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat.