Nutrition and Lifestyle Changes in Patients With Previously Untreated Stage I or Stage II Prostate Cancer

NCT00739791 | Completed

• 3 other identifiers: CDR0000612335UCSF-H5664-25348UCSF CC#04553
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Learning about changes in DNA over time in patients with prostate cancer undergoing diet and lifestyle changes may help doctors learn about the long-term effects of these changes on disease progression. PURPOSE: This clinical trial is studying nutrition and lifestyle changes in patients with previously untreated stage I or stage II prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

• Changes in gene expression in prostate tissue core biopsy samples as measured before and after a low-fat diet and lifestyle intervention

Secondary Outcomes (2)

• Correlation of quality of life changes and adherence to dietary and lifestyle changes with gene expression outcomes

• Telomere length and telomerase activity in blood samples in response to the dietary and lifestyle intervention as measured by quantitative polymerase chain reaction and telomerase repeat amplification protocol (TRAP)

Interventions

exercise intervention BEHAVIORAL

gene expression analysis GENETIC

polymerase chain reaction GENETIC

proteomic profiling GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

laboratory biomarker analysis OTHER

medical chart review OTHER

questionnaire administration OTHER

psychosocial assessment and care PROCEDURE

quality-of-life assessment PROCEDURE

support group therapy PROCEDURE

therapeutic dietary intervention PROCEDURE

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma (small cell acinar type) of the prostate * Has undergone an extended pattern biopsy (defined as 8+ cores) within the past 2 years OR is scheduled to undergo an extended pattern clinical biopsy within 6 weeks of starting study intervention and is willing to undergo 4 additional research core biopsies * No more than 33% of biopsy cores positive (\> 33% of biopsy cores positive allowed if due to microfoci of adenocarcinoma) * No more than 50% of the length of a tumor core involved by carcinoma * Clinical stage T1 or T2a disease * Previously untreated disease * Gleason score ≤ 6 with no pattern 4 or 5 histology (Gleason pattern 4 seen as a microfocus \[\< 2 mm in length\] allowed) * Prostate-specific antigen (PSA) ≤ 10.0 ng/mL (PSA \< 15 ng/mL allowed for patients with benign prostatic hyperplasia or prostatitis) * Must have had 3 serum PSA levels performed ≥ 2 weeks apart over the past year to allow calculation of a PSA doubling time * No PSA doubling time of \< 3 months * Has chosen watchful waiting as treatment PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * Living in the greater San Francisco Bay Area * Willing to make comprehensive lifestyle changes * Baseline dietary fat intake ≥ 15% * Able to participate in the exercise portion of this study, as determined by the cardiologist or primary care physician * No limited exercise tolerance precluding participation in the lifestyle intervention component of this study * No comprehensive lifestyle change similar to the lifestyle intervention used in this study * No concurrent uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Coronary artery disease requiring a revascularization procedure * Cardiac arrhythmia * Psychiatric illness/social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * No prior or other concurrent treatment for prostate cancer, including any of the following: * Surgery * Radiotherapy * Hormonal therapy (e.g., leuprolide acetate, bicalutamide, flutamide, goserelin, megestrol acetate, nilutamide, or DES/estrogen) * Chemotherapy * PC-SPES * Investigational agents * More than 4 weeks since prior and no concurrent finasteride or dutasteride * More than 4 weeks since prior and no concurrent saw palmetto or any other herbal/nutritional preparation that would affect hormone levels * More than 4 weeks since prior multivitamin/mineral and/or supplemental soy protein, vitamin E, vitamin C, selenium, fish oil, or any other preparation intended to supplement levels of omega-3 unsaturated fatty acids * More than 1 month since prior and no concurrent NSAIDs, COX-2-inhibitors, and/or aspirin used for \> 7 consecutive days

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Ornish D, Lin J, Daubenmier J, Weidner G, Epel E, Kemp C, Magbanua MJ, Marlin R, Yglecias L, Carroll PR, Blackburn EH. Increased telomerase activity and comprehensive lifestyle changes: a pilot study. Lancet Oncol. 2008 Nov;9(11):1048-57. doi: 10.1016/S1470-2045(08)70234-1. Epub 2008 Sep 15.

  PMID: 18799354 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gene Expression Profiling; Polymerase Chain Reaction; Reverse Transcriptase Polymerase Chain Reaction; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Nucleic Acid Amplification Techniques; Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Peter R. Carroll, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 22, 2008
• Study Start: September 1, 2003
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: September 14, 2012

Record last verified: 2012-09