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2 for Prostate Cancer

Phase 2
Waitlist Available
Led By Allan J Pantuck, MD
Research Sponsored by Roll International Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study Summary

High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from primary treatment failure to hormonal ablation. This is a 48 month extension to the double-blind GUP-0205-1 study, to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12, 24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The variable will be the mean PSA doubling time at the end of 12, 24,36 and 48 months.
Secondary outcome measures
Measures of tolerability (adverse events) and toxicity (clinical chemistries, etc.).
Overall efficacy responses categorized as Objective Response, Progressive Disease, Stable Disease.
Response rates in positive and negative PSA doubling times with a clinically significant positive doubling time is defined as >150% of baseline.
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2Experimental Treatment1 Intervention
Group II: 1Experimental Treatment1 Intervention
Group III: 3Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pomegranate juice
2014
Completed Phase 4
~320

Find a Location

Who is running the clinical trial?

Roll International CorporationLead Sponsor
3 Previous Clinical Trials
597 Total Patients Enrolled
2 Trials studying Prostate Cancer
213 Patients Enrolled for Prostate Cancer
Allan J Pantuck, MDPrincipal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
55 Total Patients Enrolled
2 Trials studying Prostate Cancer
55 Patients Enrolled for Prostate Cancer
Arie S Belldegrun, MDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Prostate Cancer
30 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer
2007. "Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00732043.
All > Prostate
~12 spots leftby Apr 2025
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