Pomegranate-Extract Pill in Preventing Tumor Growth in Patients With Localized Prostate Cancer Undergoing Active Surveillance
A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/Pomx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
7 other identifiers
interventional
38
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2014
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2014
CompletedStudy Start
First participant enrolled
May 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2019
CompletedResults Posted
Study results publicly available
February 5, 2020
CompletedFebruary 5, 2020
January 1, 2020
3.7 years
March 20, 2014
November 20, 2019
January 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Plasma IGF-1 From Baseline to Post-Treatment
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.
Baseline to 12 months
Secondary Outcomes (19)
Compliance: Number of Participants Who Took Study Drug Per Protocol
Up to 1 year
Incidence of Adverse Events Graded Per Common Terminology Criteria for Adverse Events (CTCAE)
Up to 1 year
Change in Plasma Biomarker Levels From Baseline: IGFBP-3
Week 13, Week 26, Week 39, Week 52
Change in Plasma Biomarker Levels From Baseline: IGF-1/GFBP-3
Week 13, Week 26, Week 39, Week 52
Change in Total Serum Prostate Specific Antigen (PSA) From Baseline
Up to 1 year
- +14 more secondary outcomes
Study Arms (2)
Group I (pomegranate-extract pill)
EXPERIMENTALPatients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week).
Group II (placebo)
PLACEBO COMPARATORPatients receive placebo PO QD for 52 weeks (+/- 1 week).
Interventions
Correlative studies
Eligibility Criteria
You may qualify if:
- Participants must have had a standard-of-care biopsy within 13 months of the baseline study visit and must have been diagnosed with low-grade, clinically localized prostate cancer (Gleason score =\< 3+3 with a PSA at baseline \< 10 ng/ml in participants \< 70 years of age, OR Gleason score =\< 3+4 with a PSA at baseline =\< 15 ng/ml in participants \>= 70 years of age); eligible participants will be those men who are able and willing to undergo AS with PSA monitoring and a scheduled biopsy performed at the end of the study
- No concurrent treatment (hormonal, radiation or systemic chemotherapy) for prostate cancer during study enrollment is planned (unless participants demonstrate clinical evidence of prostate cancer progression such as symptoms, physical exam findings, a rapidly increasing PSA, or radiologic findings which confirm disease progression)
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
- White blood cells (WBC) \>= 3000/mm\^3
- Platelets \>= 100,000 mm\^3
- Hemoglobin \>= 10 g/dL
- Total bilirubin =\< 1.5 x upper limit of institutional normal
- Alkaline phosphatase =\< 1.5 x upper limit of institutional normal
- Aspartate aminotransferase (AST) =\< 1.5 x upper limit of institutional normal
- Alanine aminotransferase (ALT) =\< 1.5 x upper limit of institutional normal
- Serum creatinine within 1.5 x upper limit of institutional normal
- Sodium 135-144 mmol/L (inclusive)
- Potassium 3.2-4.8 mmol/L (inclusive)
- Participants will be required to use a medically-approved method of birth control or abstinence if their sexual partner is of child-bearing potential
- Participants must be willing to forego foods, beverages and supplements containing pomegranate for the duration of the study
- +1 more criteria
You may not qualify if:
- Any prior surgery to the prostate within 30 days of baseline procedures; NOTE: Biopsies are not considered surgeries
- Evidence of other cancer(s) (excluding non-melanoma skin cancer) within last 5 years
- Prior pelvic radiation for any reason
- Participants cannot be taking 5-alpha-reductase inhibitors while on study or within 6 months of the baseline study visit
- Participants may not be taking carbamazepine (tegretol)
- Participants may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PFE
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- Any significant cardiac event(s) within the 12 months prior to registration, such as episode(s) of symptomatic congestive heart failure, myocardial infarction, unstable angina pectoris or persistent, stable angina pectoris, or cardiac arrhythmia requiring medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Urology San Antonio Research PA
San Antonio, Texas, 78229, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Jarrard
- Organization
- University of Wisconsin Carbone Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
David F Jarrard
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2014
First Posted
March 24, 2014
Study Start
May 8, 2014
Primary Completion
January 23, 2018
Study Completion
September 26, 2019
Last Updated
February 5, 2020
Results First Posted
February 5, 2020
Record last verified: 2020-01