Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pilot Trial of Gene Expression Modulation by Intervention With Nutrition and Lifestyle
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.


Options:
A: Inclusion Criteria:

1. Legal age (\>18 years old)
2. An interval of at least 6 weeks between prior radical prostatectomy and study enrollment
3. Karnofsky performance status of at least 70% at study entry
4. Estimated life expectancy of ≥6 months
5. Ability to read and understand English
6. Attending urologist approval
7. Signed informed consent
8. Willingness to be randomized; and
9. No contraindications to exercise as recommended by the American Thoracic Society

Exclusion Criteria:

1. Acute myocardial infarction (6 weeks)
2. Unstable angina
3. Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
4. Syncope
5. Acute endocarditis
6. Acute myocarditis or pericarditis
7. Uncontrolled heart failure
8. Acute pulmonary embolus or pulmonary infarction
9. Thrombosis of lower extremities
10. Suspected dissecting aneurysm
11. Uncontrolled asthma
12. Pulmonary edema
13. Room air desaturation at rest ≤85%
14. Respiratory failure
15. Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise; and
16. Mental impairment leading to inability to cooperate
B: Inclusion Criteria:

* Confirmed pathologic diagnosis of adenocarcinoma of pancreas or periampullary cancers, Stage I, II, or III
* Treatment included surgery alone, or adjuvant treatment with CT and/or RT
* Men and women ≥ 18 years of age
* Residents of the USA
* Surgery performed at TJUH, Philadelphia, PA
* CT or RT performed at TJUH, Jefferson system affiliate hospital, or elsewhere
* Patients receiving neoadjuvant therapy with CT or RT, or both, who subsequently are re-staged and eligible for surgery

Exclusion Criteria:

* The presence of co-morbidities that would preclude involvement in a walking program (wheelchair bound, severe arthritis, dizziness)
* Primary residence outside the USA
* Medical management alone for pancreas or periampullary cancer (i.e. not a surgical candidate)
* Stage IV (metastatic) cancer
C: 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
D: Inclusion Criteria:

* Biopsy proven prostate cancer within 2 years prior to enrolment
* PSA ≤ 10 ng/ml, Gleason-score ≤ 6, clinical localized prostate cancer ≤ cT2a or PSA ≤ 10 ng/ml, Gleason-score ≤ 7, clinical localized prostate cancer ≤ cT2a.
* Maximum 1/5 tumor positive biopsy rate
* On active surveillance (elected to forgo treatment)
* Level of testosterone normal in sera

Exclusion Criteria:

* Prior history of cancer, except for non-melanoma skin cancer, unless considered cured without signs of treatment failure for at least five years
* Less than 10 years of life expectancy
* Conditions or behaviors likely to affect the capability of participating fully in the intervention
* Moderate to severe co-morbidity (kidney, liver, heart or respiratory problems) or the general physical constitution
* Gluten intolerance
* Inflammatory bowel disease (e.g. Crohn, colitis)
* Physical handicaps

Answer: C