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| ID | Type | Description | Link |
|---|---|---|---|
| UCSF-H5664-25348 | |||
| UCSF CC#04553 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
OUTLINE:
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 score).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gene expression in prostate tissue core biopsy samples as measured before and after a low-fat diet and lifestyle intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma (small cell acinar type) of the prostate
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
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:
PRIOR CONCURRENT THERAPY:
No prior or other concurrent treatment for prostate cancer, including any of the following:
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
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| Name | Affiliation | Role |
|---|---|---|
| Peter R. Carroll, MD | University of California, San Francisco | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18799354 | Result | 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. |
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| questionnaire administration | Other |
| psychosocial assessment and care | Procedure |
| quality-of-life assessment | Procedure |
| support group therapy | Procedure |
| therapeutic dietary intervention | Procedure |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D016133 | Polymerase Chain Reaction |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D021141 | Nucleic Acid Amplification Techniques |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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