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Pilot Trial of Gene Expression Modulation by Intervention With Nutrition and Lifestyle

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Prostate Cancer

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Trial Information

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

Inclusion Criteria


- 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


- 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

- No concurrent uncontrolled illness including, but not limited to, any of the

- 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


- No prior or other concurrent treatment for prostate cancer, including any of the

- Surgery

- Radiotherapy

- Hormonal therapy (e.g., leuprolide acetate, bicalutamide, flutamide, goserelin,
megestrol acetate, nilutamide, or DES/estrogen)

- Chemotherapy


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

Peter R. Carroll, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

September 2003

Completion Date:

June 2005

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms