Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597359
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2020-10-14
Brief Title:
To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well green tea catechins work in preventing progression of prostate cancer from a low risk stage to higher risk stages in men who are on active surveillance Green tea catechins may stabilize prostate cancer and lower the chance of prostate growing
Detailed Description:
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 50 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
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive green tea catechins orally PO twice daily BID for up to 6 months in the absence of disease progression or unacceptable toxicity
ARM B Patients receive placebo PO BID for up to 6 months
After completion of study patients are followed up at approximately 7 days at 6 months and then up to 12 months
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 50 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
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive green tea catechins orally PO twice daily BID for up to 6 months in the absence of disease progression or unacceptable toxicity
ARM B Patients receive placebo PO BID for up to 6 months
After completion of study patients are followed up at approximately 7 days at 6 months and then up to 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1CA189828 | NIH | CTEP | httpsreporternihgovquickSearchUG1CA189828 |
| EA8184 | OTHER | None | None |
| ECOG-ACRIN-EA8184 | OTHER | None | None |
| EA8184 | OTHER | None | None |
| NCI-2020-07173 | REGISTRY | None | None |