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1 for Prostate Cancer

Phase 2
Waitlist Available
Led By Arie S Belldegrun, 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
Documented disease progression while on placebo in the GUP-0205-1 or GUP-0205-1XX study (a ≥100% increase over baseline serum PSA with a minimum increase of 1.0 ng/mL.
Willingness and ability to sign an informed consent document.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial tests whether pomegranate extract can delay prostate cancer progression & prolong the time between treatments for male patients who progressed during placebo treatment.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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 within-subject difference between the PSA doubling time from the end of double-blind placebo treatment to the end of open-label pomegranate extract treatment.
Secondary outcome measures
The effect of treatments on response rates for positive PSA doubling times (greater than 150% baseline), and for negative post-treatment PSA doubling time (i.e., declining PSA), and for changes in absolute PSA values.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Intervention 1

Find a Location

Who is running the clinical trial?

Roll International CorporationLead Sponsor
3 Previous Clinical Trials
767 Total Patients Enrolled
2 Trials studying Prostate Cancer
383 Patients Enrolled for Prostate Cancer
Arie S Belldegrun, MDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Prostate Cancer
200 Patients Enrolled for Prostate Cancer
Allan J Pantuck, MDPrincipal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
225 Total Patients Enrolled
2 Trials studying Prostate Cancer
225 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.
~2 spots leftby Mar 2025