Status:
COMPLETED
Nutrition and Lifestyle Changes in Patients With Previously Untreated Stage I or Stage II Prostate Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
NA
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...
Detailed Description
OBJECTIVES: * 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2005
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00739791
Start Date
September 1 2003
End Date
June 1 2005
Last Update
September 14 2012
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