A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers
Categories (click each to see list of all clinical trials associated with that category): GU (ONC), Surgical Oncology (SURGONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Schober, Jared
Contact Information:
Micki Bethea, BS
+1 402-559-8011
mbethea@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04597359?term=NCT04597359&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVE:
I. To compare the change in the percent (%) Ki-67 expression in a biopsy core positive for cancer from baseline to
end-of-study (EOS) biopsy between men on active surveillance (AS) for prostate cancer (PCa), treated with green tea
catechins (GTCs) or placebo for 6 months.
SECONDARY OBJECTIVES:
I. To assess apoptosis by caspase in tumor tissue from EOS biopsy by treatment. II. To assess % Ki-67: Apoptosis
ratio from EOS biopsy by treatment. III. To evaluate the number of biopsy cores positive for cancer from EOS biopsy
by treatment.
IV. To evaluate the percentage of any biopsy tissue core positive for cancer from EOS biopsy by treatment.
V. To evaluate % Ki-67 in EOS biopsy from the same quadrant matching the quadrant with the highest % Ki-67 at
baseline treatment.
VI. To evaluate the Gleason sum from EOS biopsy by treatment. VII. To evaluate the change in serum
prostate-specific antigen (PSA) from baseline to 3 months and to EOS by treatment.
VIII. To evaluate the safety of 6 month administration of GTC assessed by Common Toxicity Criteria (CTC) version
5.0, complete blood count (CBC), comprehensive metabolic panel (CMP) and liver function toxicities (LFTs) by
treatment.
IX. To evaluate the change in geometric mean of % Ki-67 measures in all the cores positive for cancer from baseline
to EOS biopsy by treatment.
EXPLORATORY OBJECTIVES:
I. To evaluate the change in catechin (epigallocatechin gallate [EGCG]) as indicated by change from EGCG measured
in plasma from baseline and EOS by treatment.
II. To evaluate the adherence and acceptability to GTC based on the percentage compliance using agent logs (%) and
pill counts monthly until EOS by treatment groups.
III. To evaluate the bioavailability of GTC as indicated by change from EGCG measured in plasma from baseline and
EOS by treatment groups.
PATIENT REPORTED OUTCOMES OBJECTIVES:
I. To evaluate the change in lower urinary tract symptoms (LUTS) from baseline to 3 months and to EOS using the
LUTS scale by treatment groups.
II. To evaluate the change in quality of life (QOL) scores from baseline to 3 months and to EOS using the Functional
Assessment of Cancer Therapy (FACT)-Prostate by treatment groups.