Pilot Trial of Gene Expression Modulation by Intervention With Nutrition and Lifestyle
- To measure changes in gene expression in prostate tissue core biopsy samples before and
after a low-fat diet and lifestyle intervention in patients with previously untreated
stage I or II adenocarcinoma of the prostate.
- To collect health information from these patients to enable better understanding of the
long term impact of diet and lifestyle changes on prostate cancer progression.
- Intervention phase: Patients are placed on a comprehensive lifestyle change program
comprising a low-fat vegan diet, stress management, moderate aerobic exercise, and
regular participation in a support group for 3 months.
- Follow-up phase: Patients undergo core tissue biopsies at baseline and at 3 months for
genomic and gene expression analysis. Insulin-like growth factor 1 (IGF-1) and
selenium-binding protein 1 levels are measured by quantitative reverse
transcription-polymerase chain reaction (PCR). Patients also undergo blood sample
collection periodically for biomarker analysis, proteomic analysis, and for telomere
length and telomerase activity analysis as measured by quantitative PCR and telomerase
repeat amplification protocol (TRAP). Blood and urine samples are also collected and
stored for future analysis.
Patients complete questionnaires at baseline, at 3 months, and then every 6-12 months for up
to 3 years to assess dietary and lifestyle behaviors (exercise, stress management practice,
and group support), quality of life, and psychological adjustment. Questionnaires include
the Semi-Quantitative Food Frequency Questionnaire; the SF-36 Health Survey; the UCLA
Prostate Cancer Index; the Impact of Event Scale; the Memorial Anxiety Scale for Prostate
Cancer; the Post Traumatic Growth Inventory; the Mindful Attention Awareness Scale; and the
Received Social Support subscale from the Berlin Social Support Scale.
Patients' medical records are reviewed every 6-12 months for up to 3 years to collect
information on clinical events and biomarkers (e.g., prostate-specific antigen and Gleason
Primary Purpose: Treatment
Changes in gene expression in prostate tissue core biopsy samples as measured before and after a low-fat diet and lifestyle intervention
Peter R. Carroll, MD
University of California, San Francisco
United States: Federal Government