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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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
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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
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