At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 38 enrolled
Drug / intervention
Pomegranate-Extract Pill +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/Pomx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
In Brief
A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Pharmacological Study, and 2 other interventions for PSA Level Less Than or Equal to Fifteen and 5 related conditions. Completed, enrolled 38 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPSA Level Less Than or Equal to Fifteen, PSA Level Less Than Ten, Stage I Prostate Cancer AJCC v7, Stage II Prostate Cancer AJCC v7, Stage IIA Prostate Cancer AJCC v7, Stage IIB Prostate Cancer AJCC v7
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartMay 2014
Primary CompletionJan 2018
Study CompletionSep 2019
TodayJul 2026
First PostedMar 24, 2014
Enrollment StartMay 8, 2014
Primary CompletionJan 23, 2018
Study CompletionSep 26, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 12.3 years ago
Interventions
Laboratory Biomarker Analysisother
Correlative studies
Pharmacological Studyother
Correlative studies
Placeboother
Given PO
Pomegranate-Extract Pilldrug
Given PO