NCT00596011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

September 3, 2014

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2018

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

6.4 years

First QC Date

January 7, 2008

Results QC Date

August 15, 2014

Last Update Submit

October 2, 2019

Conditions

Prostatic Hyperplasia

Keywords

prostate cancerPINpolyphenon EEGCG

Outcome Measures

Primary Outcomes (2)

  • Rate of Progression to Prostate Cancer (PCa)

    Number of participants with diagnosis of high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP) who progressed to prostate cancer (PCa) at one year.

    12 months

  • Rate of Progression From HGPIN to ASAP or PCa

    Analyses of participants reaching a definitive endpoint. Number of baseline HGPIN participants who progressed to ASAP or PCa.

    12 months

Secondary Outcomes (3)

  • Treatment Emergent Adverse Events (AEs)

    12 months

  • Occurrence of Grade 3 or Higher Adverse Events (AEs)

    12 months

  • Median Serum Total Prostatic Specific Antigen (tPSA)

    12 months

Other Outcomes (2)

  • Change in Scores - Lower Urinary Tract Symptom (LUTS)

    1 year

  • Effect of Polyphenon E on the Fundamental Molecular Pathways

    12 months

Study Arms (2)

Polyphenon E Treatment

ACTIVE COMPARATOR

Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)

Drug: Polyphenon E

Placebo Administration

PLACEBO COMPARATOR

Matching placebo BID

Drug: Placebo

Interventions

Polyphenon EDRUG

Polyphenon E, at a dose of 400 mgs EGCG (200 mgs BID) for 1 year in men diagnosed with HGPIN and ASAP.

Also known as: green tea catechins, PolyE
Polyphenon E Treatment
PlaceboDRUG

Matching placebo BID

Placebo Administration

Eligibility Criteria

Age30 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate biopsy with a minimum of 8 cores performed within 6 months of study entry that shows no evidence of cancer.
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Florida/Shands-Department of Urology

Gainesville, Florida, 32610, United States

Location

University of Florida - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Watson Clinic Center for Research, Inc.

Lakeland, Florida, 33805, United States

Location

H Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

James A Haley VA

Tampa, Florida, 33612, United States

Location

University of Chicago - Department of Surgery

Chicago, Illinois, 60637, United States

Location

Overton Brooks VA Medical Center

Shreveport, Louisiana, 71101-4295, United States

Location

LSU Health Sciences Center, Feist-Weiller Cancer Center

Shreveport, Louisiana, 71130, United States

Location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Jefferson Medical College - Department of Urology

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (5)

  • Kim SJ, Amankwah E, Connors S, Park HY, Rincon M, Cornnell H, Chornokur G, Hashim AI, Choi J, Tsai YY, Engelman RW, Kumar N, Park JY. Safety and chemopreventive effect of Polyphenon E in preventing early and metastatic progression of prostate cancer in TRAMP mice. Cancer Prev Res (Phila). 2014 Apr;7(4):435-44. doi: 10.1158/1940-6207.CAPR-13-0427-T. Epub 2014 Feb 5.

    PMID: 24501325BACKGROUND

  • Kumar NB, Pow-Sang JM, Spiess PE, Park JY, Chornokur G, Leone AR, Phelan CM. Chemoprevention in African American Men With Prostate Cancer. Cancer Control. 2016 Oct;23(4):415-423. doi: 10.1177/107327481602300413.

    PMID: 27842331RESULT

  • Kumar NB, Pow-Sang J, Spiess PE, Park J, Salup R, Williams CR, Parnes H, Schell MJ. Randomized, placebo-controlled trial evaluating the safety of one-year administration of green tea catechins. Oncotarget. 2016 Oct 25;7(43):70794-70802. doi: 10.18632/oncotarget.12222.

    PMID: 28053292RESULT

  • Kumar NB, Patel R, Pow-Sang J, Spiess PE, Salup R, Williams CR, Schell MJ. Long-term supplementation of decaffeinated green tea extract does not modify body weight or abdominal obesity in a randomized trial of men at high risk for prostate cancer. Oncotarget. 2017 Jun 29;8(58):99093-99103. doi: 10.18632/oncotarget.18858. eCollection 2017 Nov 17.

    PMID: 29228755RESULT

  • Kumar NB, Pow-Sang J, Egan KM, Spiess PE, Dickinson S, Salup R, Helal M, McLarty J, Williams CR, Schreiber F, Parnes HL, Sebti S, Kazi A, Kang L, Quinn G, Smith T, Yue B, Diaz K, Chornokur G, Crocker T, Schell MJ. Randomized, Placebo-Controlled Trial of Green Tea Catechins for Prostate Cancer Prevention. Cancer Prev Res (Phila). 2015 Oct;8(10):879-87. doi: 10.1158/1940-6207.CAPR-14-0324. Epub 2015 Apr 14.

    PMID: 25873370DERIVED

MeSH Terms

Conditions

Prostatic HyperplasiaProstatic Neoplasms

Interventions

polyphenon E

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasms

Limitations and Caveats

Primary Endpoint: Progression to PCa. Recent evidence demonstrates ASAP is a stronger diagnostic predictor associated with PCa compared to HGPIN. Due to this evidence and recruitment challenges, we revised inclusion criteria to include men with ASAP.

Results Point of Contact

Title
Nagi Kumar, Ph.D.
Organization
H. Lee Moffitt Cancer Center and Research Institute
nagi.kumar@moffitt.org
813-745-6885

Study Officials

  • Nagi Kumar, PhD

    H. Lee Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

November 14, 2007

Primary Completion

March 25, 2014

Study Completion

July 27, 2018

Last Updated

October 4, 2019

Results First Posted

September 3, 2014

Record last verified: 2019-10

Locations

US(10)