Sunphenon for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate Cancer+1 MoreSunphenon - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial will evaluate the safety, effectiveness and bioavailability of a standardized Green Tea Catechin formulation given over 24 months to men with low- to intermediate-grade prostate managed on active surveillance.

Eligible Conditions
  • Prostate Cancer
  • Prostate Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 24 months

24 months
Rate of Progression to Prostate Cancer (PCa)
Month 24
Occurrence of Adverse Events per Study Arm
Baseline to 24 months
Acceptability of Green Tea Catechins vs.Placebo
Adherence of Green Tea Catechins vs.Placebo
Change in (prostate-specific antigen) PSA and PSA kinetics
Change in gene expression panel
Proportion of men with no cancer

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Sunphenon® 90D
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

135 Total Participants · 2 Treatment Groups

Primary Treatment: Sunphenon · Has Placebo Group · Phase 2

Sunphenon® 90D
Drug
Experimental Group · 1 Intervention: Sunphenon · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,070 Previous Clinical Trials
41,128,979 Total Patients Enrolled
536 Trials studying Prostate Cancer
502,261 Patients Enrolled for Prostate Cancer
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
502 Previous Clinical Trials
125,793 Total Patients Enrolled
25 Trials studying Prostate Cancer
3,523 Patients Enrolled for Prostate Cancer
Nagi Kumar, PhD, RD, FADAPrincipal InvestigatorMoffitt Cancer Center

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no history of renal or hepatic disease, including history of hepatitis B and C.
You are at least 18 years old.
You have a PSA level of <10 ng/mL or a PSAD of <0.
You are willing to abstain from consuming any supplements containing GTC.