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NCT02095145 · ClinicalTrials.gov registry record · Phase 2
Pomegranate-Extract Pill in Preventing Tumor Growth in Patients With Localized Prostate Cancer Undergoing Active Surveillance
A Phase 2 study of Stage IIB Prostate Cancer AJCC v7 and Stage I Prostate Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 4
- Study locations
NCT02095145: Completed Phase 2 study of Stage IIB Prostate Cancer AJCC v7 and Stage I Prostate Cancer AJCC v7, sponsored by National Cancer Institute (NCI).
NCT02095145 is a Phase 2 study of Stage IIB Prostate Cancer AJCC v7 and Stage I Prostate Cancer AJCC v7 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants, below the 179-participant average among 3 other Stage IIB Prostate Cancer AJCC v7 trials with a reported enrollment target (79% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02095145, a Phase 2 study of Stage IIB Prostate Cancer AJCC v7 and Stage I Prostate Cancer AJCC v7, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 4
- Study locations
Study Summary
This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth in patients with prostate cancer that is limited to a certain part of the body (localized), who have chosen observation as their treatment plan. The use of pomegranate-extract pill may slow disease progression in patients with localized prostate cancer.
Primary Outcome
The primary endpoint for modulation of intermediate endpoint biomarkers will be the change in the plasma levels of IGF-1 by a quantitative assay (ELISA) from pre-study to post-treatment. The difference between these time points for the placebo group and the pomegranate fruit extract (PFE) group will be tested using a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test.
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- DRUG Pomegranate-Extract Pill
Study Locations (4)
Massachusetts
- Lahey Hospital and Medical Center - Burlington
Minnesota
- University of Minnesota/Masonic Cancer Center - Minneapolis
Texas
- Urology San Antonio Research PA - San Antonio
Wisconsin
- University of Wisconsin Hospital and Clinics - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2014-05-08 |
| Est. Completion | 2019-09-26 |
| Phase | Phase 2 |
What the finished NCT02095145 record still lists
NCT02095145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 179-participant average among 3 other Stage IIB Prostate Cancer AJCC v7 trials with a reported enrollment target (79% lower).
The record links to 6 conditions, with Stage IIB Prostate Cancer AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT02095145 reports a single indexed study location in Massachusetts, Minnesota, Texas.
Frequently Asked Questions
What is clinical trial NCT02095145 about?
NCT02095145 is a clinical study titled "Pomegranate-Extract Pill in Preventing Tumor Growth in Patients With Localized Prostate Cancer Undergoing Active Surveillance". This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth in patients with prostate cancer that is limited to a certain part of the body (localized), who have chosen observation as their treatment plan. The use of pomegranate-extract pill may slow disease progression...
What is the current status of trial NCT02095145?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2014-05-08. Estimated completion is 2019-09-26.
What conditions does trial NCT02095145 study?
This clinical trial studies the following conditions: Stage IIB Prostate Cancer AJCC v7, Stage I Prostate Cancer AJCC v7, Stage IIA Prostate Cancer AJCC v7, Stage II Prostate Cancer AJCC v7, PSA Level Less Than or Equal to Fifteen.
What interventions are being tested in trial NCT02095145?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Pomegranate-Extract Pill (DRUG).
Who is sponsoring clinical trial NCT02095145?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02095145 being conducted?
This trial has 4 study locations across Massachusetts, Minnesota, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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