Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase II, Randomized, Double-blind, Multi-centered Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia (HGPIN) or Atypical Small Acinar Proliferation (ASAP)
Brief Summary: The purpose of this study was to determine whether the daily consumption of decaffeinated green tea catechins (Polyphenon E®) for 1 year reduces the rate of progression to prostate cancer (PCa) in men diagnosed with HGPIN or ASAP. The aim was to recruit and treat 240 (120 men/arm) men diagnosed with the prostate condition HGPIN or ASAP with a capsule form of standardized green tea extract called Polyphenon E or placebo for a 12-month period and see if it can prevent progression of the prostate condition to prostate cancer. Investigators wanted to see if Polyphenon E reduces lower urinary tract symptoms and if this can be taken safely over one year. Investigators wanted to study how Polyphenon E is able to slow the progression to prostate cancer, or the mechanism of action of Polyphenon E. If the safety and the effects of Polyphenon E on slowing down the progression of prostate cancer is shown in our study, this will be a safe way of treating men who are at high risk or men like you who have a prostate condition that increases your chances of getting prostate cancer, so that we can prevent prostate cancer in the future.


Options:
A: Inclusion Criteria:

* Histologically confirmed cervical intraepithelial neoplasia 1 (CIN 1) AND oncogenic human papillomavirus (HPV) positivity
* At increased risk for developing cervical cancer due to \>= 1 of the following criteria (documented 6-12 months ago)\*:

  * Positive oncogenic HPV on DNA hybrid capture
  * Low-grade squamous intraepithelial lesion cytology
  * Histopathologically documented CIN 1 on cervical biopsy \[Note: \*Patients must now have current CIN 1 by histology or colposcopy AND HPV positivity\]
* Cervical dysplasia by colposcopy OR positive biopsy
* No invasive cervical cancer or high-grade intraepithelial neoplasia on cervical biopsy or endocervical curettage
* ECOG performance status \< 2
* Total bilirubin \< 2 times upper limit of normal (ULN)
* AST \< 2 times ULN
* ALT normal
* Creatinine \< 2.0 mg/dL
* Able and willing to return to clinic for study visits once every 4 weeks for the duration of the study
* No history of allergic reaction to tea or related dietary products
* No HIV positive patients (or AIDS/HIV-associated complex)
* No uncontrolled intercurrent illness including, but not limited to, any of the following:

  * Ongoing or active infection other than HPV
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
  * Psychiatric illness/social situation that would limit compliance with study requirements
* No history of any cancer except nonmelanoma skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No regular intake of 6 or more servings of tea per week within 1 month prior to study entry
* No treatment for genital condyloma within 30 days prior to study entry
* No prior pelvic irradiation
* No concurrent tea (green, black, or oolong) or tea-derived products
* No other concurrent investigational agents
B: INCLUSION CRITERIA:

* Clinician recommends repeat biopsy of the prostate ("Repeat" is defined as any recommended biopsy of the prostate subsequent to an earlier biopsy of the prostate)

EXCLUSION CRITERIA:

* Definitive invasive prostate cancer on initial biopsy
* Significant active medical illness that in the opinion of the clinician would preclude protocol treatment.
* History of ventricular tachycardia or ventricular fibrillation
* Subject reported use of fish oil (greater than 1 gram per day) or green tea supplement within 30 days before Day 1 of study treatment
* Subject reported use of fish oil ≤ 1 gram per day and unwilling to discontinue use for the duration of the trial
* Use of warfarin or need for therapeutic anticoagulation at time of biopsy or at anytime during the course of the trial.
* Subject reported allergy or sensitivity to fish oil, olive oil or green tea
* Subject reported history of hemophilia, van Willebrands disease or other bleeding disorder, except when the subject is evaluated by a hematologist who determines that fish oil supplementation is not contraindicated.
* Total bilirubin greater than institutional upper limit of normal
* Concurrent high risk study participation
C: Inclusion Criteria:

- subjects who present one or more adenomatous polyps on colonoscopy.

Exclusion Criteria:

* subjects who denied to participate in this study
* subjects who present inflammatory bowel diseases such as ulcerative colitis or crohn's disease
* subjects who received partial or total colectomy due to colon cancer or other colonic diseases.
* subjects who are pregnant
* subjects who are on aspirin or NSAIDS for any reasons
* subjects who have received a transplant of any major organ or who are on immunosuppressants for any reason
* subjects who are unable to perform a bowel prep or who present poor bowel prep for colonoscopy
D: Inclusion Criteria:

* Men with a diagnosis of HGPIN or ASAP in a minimum of 1 of 8 cores from a biopsy performed within six months of study entry. Diagnosis of HGPIN or ASAP (which includes men with ASAP and HGPIN) via trans-rectal ultrasound (TRUS biopsy) is also considered acceptable for inclusion.
* Prostate biopsy with a minimum of 8 cores performed within 6 months of study entry that shows no evidence of cancer.
* 30-80 years of age at the time of registration
* PSA ≤10 ng/ml
* Omnivorous diet
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Participants must have normal organ and marrow function as demonstrated by the following parameters being within normal institutional limits: complete blood count (CBC); liver function tests (LFTs); albumin, total and direct bilirubin, alkaline phosphatase, aspartic transaminase (AST), alanine transaminase (ALT), and total protein), PT/PTT, and LDH; serum creatinine \<1.5 mg/dl or measured creatinine clearance 60 cc/min
* Absence of consumption of toremifene citrate, finasteride, testosterone, dehydroepiandrosterone (DHEA) or other testosterone-like supplements or medications which have known impact on PSA within 30 days of informed consent, or dutasteride within 90 days of informed consent
* Absence of consumption of any nutritional or herbal supplements containing green tea or green tea polyphenols
* No or low regular tea consumption (no more than 3 servings of hot tea or 6 servings of iced tea per week)
* Willing to discontinue current vitamin/mineral supplement use and substitute with a standard multivitamin supplement provided for the study
* Willing to use an effective method of contraception, if the partner is of child-bearing age, while on study
* Willing to comply with proposed visit and treatment schedule
* Able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* Evidence of acute prostatitis or urinary tract infection at the time of PSA measurement; men may be enrolled 30 days after completion of treatment, provided all other eligibility criteria are met
* Current or prior history of prostate cancer or other malignancies (exceptions include non-melanoma skin cancer or other cancer with no evidence of tumor recurrence 5 years after definitive treatment)
* History of renal or hepatic disease, including history of hepatitis B, C or delta
* Participation in any other investigational study or use of any other investigational agents within 30 days of study entry
* History of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to Polyphenon E or the inactive components present in Polyphenon E and placebo capsules.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any psychological, familial, sociological or other concomitant condition that would not allow adequate compliance with the study protocol
* History of medical conditions that may predispose the participant to gastrointestinal bleeding (acute or chronic gastritis or colitis, or acute diverticulitis or hemorrhoids)
* Members of all races and ethnic groups are eligible for this trial. Since this is an investigation targeting men with HGPIN or ASAP, women are not eligible for the study.

Answer: D