Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer (CLIPP)

This study is an investigator initiated clinical study. A prospective, single arm unblinded, open label study will be carried out to determine the feasibility of recruitment, retention and adherence of 30 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.

Introduction Androgen deprivation therapy (ADT) has been demonstrated to improve disease free and over-all survival in men with prostate cancer (PCa). ADT for PCa is associated with adverse cardio-metabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. This reduces quality of life (QoL) and potentially affects mortality. There is paucity of data regarding comprehensive lifestyle interventions in men on ADT for Pca. Existing studies used non-standardized interventions or lack data on metabolic risk factors. CLIPP is designed to address these gaps by using an intervention modelled after the Diabetes Prevention Program (DPP), a standardized multi-component intervention with demonstrated effectiveness in reducing diabetes risk factors that has been successfully adapted for multiple disease types including breast cancer. Intervention: 24 Weeks Health Coaching Weekly Serum & Urine Baseline, Week 12 and Week 24 Anthropometric Measures Questionnaires Dual-energy X-ray absorptiometry (DXA) at Baseline and Week 24

Diabetes Prevention program and Comprehensive Lifestyle Improvement Program consisting of low calorie diet, physical activity, sleep optimization and stress management

Recruit 30 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.

PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5. 1=Poor 2=Fair 3=Good 4=Very Good 5= Excellent

Expanded Prostate Cancer Index Composite Short Form (EPIC-26) - Scale of Measurement 0 to 4. 0=No Problem 1=Very Small problem 2=Small Problem 3=Moderate problem 4=Big Problem

Inflammation markers measured will include Interleukin-6, Interleukin 1-beta, Interleukin-8, stromal cell derived factor 1-alpha & basic fibroblast growth factor.

Determine the effect of comprehensive lifestyle modification intervention on angiogenesis, markers, important mechanisms for prostate cancer progression using blood, serum and urine. Angiogenesis markers will include vascular endothelial growth factor & plasma placental growth factor) using Enzyme Linked Immunosorbent Assay (ELISA).

Inclusion Criteria: Diagnosed with prostate cancer Stage I, II or IV On androgen deprivation therapy with last 5 years Willing to participate in a lifestyle modification program Willing to modify diet and eating practices Willing to participate in blood collection, urine collection and measurements Minimum of 30 days since participating in another study/trial English speaking 40 years of age or older Exclusion Criteria: Currently participating in another study or trial Currently in hospice Inability to walk two city blocks Inability to comprehend informed consent or procedural requirements Digestive Diseases (IBD, Diverticulitis, etc) that might prevent him from increasing fruit and vegetable intake