NCT01928485

Green Tea Extract in Treating Patients With Low-Risk Prostate Cancer

Terminated Phase 2 Results posted Last updated 22 October 2020

What this trial tests

Phase 2 trial testing active surveillance in Stage I Prostate Cancer in 6 participants. Terminated before completion.

Timeline

30 August 2013

Primary endpoint
5 October 2016

7 November 2016

Quick facts

Lead sponsor	Sanjay Gupta PhD
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	30 August 2013
Primary completion	5 October 2016
Estimated completion	7 November 2016
Sites	1 location across United States

Drugs / interventions tested

• active surveillance
• Sunphenon — full drug profile →
• laboratory biomarker analysis — full drug profile →
• Questionnaire Administration

Conditions studied

• Stage I Prostate Cancer — all drugs for Stage I Prostate Cancer →
• Stage IIA Prostate Cancer — all drugs for Stage IIA Prostate Cancer →
• Stage IIB Prostate Cancer — all drugs for Stage IIB Prostate Cancer →

Sponsor

Sanjay Gupta PhD

Who can join

Adults 45 to 85, male only, with Stage I Prostate Cancer or Stage IIA Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total-PSA (tPSA) Levels Primary · From baseline at 52 weeks

tPSA serum levels

Group	Value	95% CI
Arm A (Active Surveillance)	7.8	± 2.29
Arm B (Sunphenon)	5.1	± NA

Changes in the f/tPSA Ratio Primary · From baseline at 52 weeks

The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

Group	Value	95% CI
Arm A (Active Surveillance)	0.16	± 0.07
Arm B (Sunphenon)	0.16	± NA

Changes in IGF-I Levels Primary · Baseline to 52 weeks

The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

Group	Value	95% CI
Arm A (Active Surveillance)	5.28	± 0.1
Arm B (Sunphenon)	2.12	± NA

Changes in the IGF-I/fPSA Ratio Primary · Baseline up to 52 weeks

The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

Group	Value	95% CI
Arm A (Active Surveillance)	4.48	± 0.77
Arm B (Sunphenon)	3.02	± NA

Changes in the Level of IGFBP-3 Primary · Baseline to 52 weeks

The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

Group	Value	95% CI
Arm A (Active Surveillance)	1.82	± 0.93
Arm B (Sunphenon)	5.54	± NA

Changes in the Level of VEGF Primary · Baseline up to 52 weeks

The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

Group	Value	95% CI
Arm A (Active Surveillance)	29.8	± 20.6
Arm B (Sunphenon)	0	± NA

Changes in the Levels of Free-PSA (f-PSA) Primary · from baseline at 52 weeks

The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.

Group	Value	95% CI
Arm A (Active Surveillance)	1.2	± 0.17
Arm B (Sunphenon)	0.7	± NA

Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA) Secondary · Up to 52 weeks

The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures analysis of variance (ANOVA).

Group	Value	95% CI
Arm A (Active Surveillance)	0.53	± 0.14
Arm B (Sunphenon)	0.60	± 0.23

Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores Secondary · Baseline

Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.

Urinary Incontinence

Group	Value	95% CI
Arm A (Active Surveillance)	2.33	± 2.18
Arm B (Sunphenon)	3.0	± 2.65

Urinary Irritation

Group	Value	95% CI
Arm A (Active Surveillance)	0.54	± 0.66
Arm B (Sunphenon)	1.5	± 1.37

Bowel Function

Group	Value	95% CI
Arm A (Active Surveillance)	0.21	± 0.41
Arm B (Sunphenon)	0.16	± 0.41

Sexual Function

Group	Value	95% CI
Arm A (Active Surveillance)	3.04	± 1.36
Arm B (Sunphenon)	4.16	± 1.60

Hormonal Function

Group	Value	95% CI
Arm A (Active Surveillance)	0.05	± 0.22
Arm B (Sunphenon)	0.0	± 0.0

Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores Secondary · At 24 weeks

Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.

Urinary Incontinence

Group	Value	95% CI
Arm A (Active Surveillance)	2.66	± 2.14
Arm B (Sunphenon)	3.0	± 2.65

Urinary Irritation

Group	Value	95% CI
Arm A (Active Surveillance)	0.46	± 0.66
Arm B (Sunphenon)	1.5	± 1.64

Bowel Function

Group	Value	95% CI
Arm A (Active Surveillance)	0.16	± 0.38
Arm B (Sunphenon)	0.33	± 0.51

Sexual Function

Group	Value	95% CI
Arm A (Active Surveillance)	3.12	± 1.15
Arm B (Sunphenon)	4.16	± 1.60

Hormonal Function

Group	Value	95% CI
Arm A (Active Surveillance)	0.05	± 0.22
Arm B (Sunphenon)	0.0	± 0.0

Quality of Life (QOL) Assessed by Mean Expanded Prostate Cancer Index Composite (EPIC-26) Scores Secondary · at 3.5 years from start of study

Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.

Urinary Incontinence

Group	Value	95% CI
Arm A (Active Surveillance)	2.41	± 1.97
Arm B (Sunphenon)	3.0	± 2.65

Urinary Irritation

Group	Value	95% CI
Arm A (Active Surveillance)	1.08	± 1.35
Arm B (Sunphenon)	1.33	± 1.50

Bowel Function

Group	Value	95% CI
Arm A (Active Surveillance)	0.54	± 0.83
Arm B (Sunphenon)	0.16	± 0.41

Sexual Function

Group	Value	95% CI
Arm A (Active Surveillance)	3.08	± 1.21
Arm B (Sunphenon)	3.83	± 1.47

Hormonal Function

Group	Value	95% CI
Arm A (Active Surveillance)	0.10	± 0.30
Arm B (Sunphenon)	0.0	± 0.0

Quality of Life (QOL) Assessed by Mean Medical Outcomes Study 12-item Short Form Health Survey (SF-12) Secondary · Baseline

Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.

PCS

Group	Value	95% CI
Arm A (Active Surveillance)	52.78	± 4.07
Arm B (Sunphenon)	55.89	± 0.0

MCS

Group	Value	95% CI
Arm A (Active Surveillance)	56.79	± 1.18
Arm B (Sunphenon)	52.98	± 0.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days after treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A (Active Surveillance)

Serious: 0/4 (0%)

Deaths: 0/4

Arm B (Sunphenon)

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (4 terms — click to expand)

Reaction	System	Arm A (Active Surveillance)	Arm B (Sunphenon)
Dysuria	Renal and urinary disorders	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—
Vertigo	Ear and labyrinth disorders	—	—
Anxiety	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT01928485 adverse events section.

Sponsor's own description

This randomized phase II trial studies how well green tea extract works in treating patients with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or slow the growth of certain cancers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.