Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial Neoplasia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00596011 |
Recruitment Status :
Completed
First Posted : January 16, 2008
Results First Posted : September 3, 2014
Last Update Posted : October 4, 2019
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Condition or disease | Intervention/treatment | Phase |
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Prostatic Hyperplasia | Drug: Polyphenon E Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 97 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official 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) |
Actual Study Start Date : | November 14, 2007 |
Actual Primary Completion Date : | March 25, 2014 |
Actual Study Completion Date : | July 27, 2018 |
Arm | Intervention/treatment |
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Active Comparator: Polyphenon E Treatment
Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
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Drug: Polyphenon E
Polyphenon E, at a dose of 400 mgs EGCG (200 mgs BID) for 1 year in men diagnosed with HGPIN and ASAP.
Other Names:
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Placebo Comparator: Placebo Administration
Matching placebo BID
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Drug: Placebo
Matching placebo BID |
- Rate of Progression to Prostate Cancer (PCa) [ Time Frame: 12 months ]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.
- Rate of Progression From HGPIN to ASAP or PCa [ Time Frame: 12 months ]Analyses of participants reaching a definitive endpoint. Number of baseline HGPIN participants who progressed to ASAP or PCa.
- Treatment Emergent Adverse Events (AEs) [ Time Frame: 12 months ]Safety of Polyphenon E (200 mg EGCG bid for one year) in men with HGPIN or ASAP. Number of participants with AEs Possibly or Probably related to treatment.
- Occurrence of Grade 3 or Higher Adverse Events (AEs) [ Time Frame: 12 months ]Number of participants with AEs grade 3 or higher, per treatment arm.
- Median Serum Total Prostatic Specific Antigen (tPSA) [ Time Frame: 12 months ]Median ng/mL serum tPSA post treatment, per treatment arm.
- Change in Scores - Lower Urinary Tract Symptom (LUTS) [ Time Frame: 1 year ]Change in score from baseline to 1 year. LUTS represent a common conglomeration of storage, voiding, and post-micturition symptoms with reported debilitating effect on quality of life. Symptom severity related to urinary frequency, nocturia, weak urinary stream, hesitancy, intermittency, incomplete bladder emptying and urinary urgency are assessed. We utilized the American Urological Association Symptom Score for the evaluation LUTS in this patient population. Symptom Frequency Scores: 0 = Not at all, 1 = Less than 1 time in 5, 2 = Less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. Total Symptom Score = Sum of individual scores of the 7 symptoms. (minimum possible score=0; maximum possible score =35; Range of scores and significance: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms.
- Effect of Polyphenon E on the Fundamental Molecular Pathways [ Time Frame: 12 months ]Explore the effects of Polyphenon E on the fundamental molecular pathways contributing to chemopreventive activity of Polyphenon E in the prostate. This exploratory aim is ongoing.

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596011
United States, Florida | |
University of Florida/Shands-Department of Urology | |
Gainesville, Florida, United States, 32610 | |
University of Florida - Jacksonville | |
Jacksonville, Florida, United States, 32209 | |
Watson Clinic Center for Research, Inc. | |
Lakeland, Florida, United States, 33805 | |
H Lee Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
James A Haley VA | |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
University of Chicago - Department of Surgery | |
Chicago, Illinois, United States, 60637 | |
United States, Louisiana | |
Overton Brooks VA Medical Center | |
Shreveport, Louisiana, United States, 71101-4295 | |
LSU Health Sciences Center, Feist-Weiller Cancer Center | |
Shreveport, Louisiana, United States, 71130 | |
United States, Minnesota | |
Minneapolis VA Medical Center | |
Minneapolis, Minnesota, United States, 55417 | |
United States, Pennsylvania | |
Jefferson Medical College - Department of Urology | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Nagi Kumar, PhD | H. Lee Moffitt Cancer Center |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00596011 |
Other Study ID Numbers: |
MCC-15008 R01CA12060-01A1 ( Other Identifier: NIH ) |
First Posted: | January 16, 2008 Key Record Dates |
Results First Posted: | September 3, 2014 |
Last Update Posted: | October 4, 2019 |
Last Verified: | October 2019 |
prostate cancer PIN polyphenon E EGCG |
Prostatic Intraepithelial Neoplasia Prostatic Hyperplasia Hyperplasia Pathologic Processes Neoplasms |
Prostatic Diseases Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |