Please select the arm or intervention descriptions that belong 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: Arm Label: Arm I; Type: EXPERIMENTAL; Interventions: Dietary Supplement: defined green tea catechin extract, Other: laboratory biomarker analysis | Arm Label: Arm II; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo, Other: laboratory biomarker analysis | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Arm II | Intervention Type: DIETARY_SUPPLEMENT; Name: defined green tea catechin extract; Assigned to Arm(s): Arm I | Intervention Type: OTHER; Name: laboratory biomarker analysis; Assigned to Arm(s): Arm I, Arm II
B: Arm Label: Arm I (FO, GT catechin extract); Type: EXPERIMENTAL; Interventions: Dietary Supplement: green tea catechin extract, Dietary Supplement: fish oil | Arm Label: ArmII (FO placebo, GT catechin extract); Type: EXPERIMENTAL; Interventions: Dietary Supplement: green tea catechin extract, Other: placebo | Arm Label: Arm III (FO, GT placebo); Type: EXPERIMENTAL; Interventions: Dietary Supplement: fish oil, Other: placebo | Arm Label: Arm IV (FO placebo, GT placebo); Type: PLACEBO_COMPARATOR; Interventions: Other: placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: green tea catechin extract; Assigned to Arm(s): Arm I (FO, GT catechin extract), ArmII (FO placebo, GT catechin extract) | Intervention Type: DIETARY_SUPPLEMENT; Name: fish oil; Assigned to Arm(s): Arm I (FO, GT catechin extract), Arm III (FO, GT placebo) | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Arm III (FO, GT placebo), Arm IV (FO placebo, GT placebo) | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Arm IV (FO placebo, GT placebo), ArmII (FO placebo, GT catechin extract)
C: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: GTE group; Type: EXPERIMENTAL; Interventions: Dietary Supplement: GTE (green tea extract) | Intervention Type: DIETARY_SUPPLEMENT; Name: GTE (green tea extract); Assigned to Arm(s): GTE group
D: Arm Label: Polyphenon E Treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Polyphenon E | Arm Label: Placebo Administration; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Polyphenon E; Assigned to Arm(s): Polyphenon E Treatment | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Administration

Answer: D