Patients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week).

Patients receive placebo PO QD for 52 weeks (+/- 1 week).

Patients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Pomegranate-Extract Pill: Given PO

Group I (Pomegranate-extract Pill)

Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO

Group II (Placebo)

Total

Age, Customized

The final report for this study contains data for participant 'gender', the study team would like to note this for consistency.

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Eastern Cooperative Oncology Group (ECOG) 0 = Fully active, able to carry on all pre-disease performance without restriction
1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

ECOG Performance Status

Systolic Blood Pressure

Diastolic Blood Pressure

Temperature

Pulse

Height

Weight

Body Mass Index

History or Baseline Presence of Disease / Abnormality

The Gleason Score is a grading system used to determine the aggressiveness of prostate cancer, scored 1-5 with 1 being healthy tissue and 5 being abnormal. Prostate cancers are assigned 2 scores to define the 2 most prevalent tissue types. They are added together (total range of 2-10). Typical scores fall between 6-10, the higher the overall score, the more likely the cancer will spread.

Gleason Score

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.

Change in Plasma IGF-1 From Baseline to Post-Treatment

Summarized by treatment arm with descriptive statistics, and tested for imbalance using Wilcoxon rank-sum test. Reported for each visit per protocol at Week 13, Week 26, Week 39, and Week 52 (end of study).

Compliance: Number of Participants Who Took Study Drug Per Protocol

Patient toxicity throughout the study will be summarized in several ways; the presence or absence of any toxicity, worst CTCAE grade, and strongest investigator-defined relationship will all be examined and characterized by treatment arm, and analyzed appropriately (Wilcoxon rank-sum for ordinal data, Fisher's exact test for dichotomous data, and log rank test for time to event data).

Incidence of Adverse Events Graded Per Common Terminology Criteria for Adverse Events (CTCAE)

Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.

Change in Plasma Biomarker Levels From Baseline: IGFBP-3

Change in Plasma Biomarker Levels From Baseline: IGF-1/GFBP-3

Change in Total Serum Prostate Specific Antigen (PSA) From Baseline

Patients receive pomegranate-extract pill orally once a day for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Pomegranate-Extract Pill: Given PO

Patients receive placebo orally once a day for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO

Change in Serum Testosterone

PSA DT will be determined from PSA values obtained during study participation (baseline and weeks 13, 26, 39 and 52). The secondary endpoint of PSA DT is based on the value at study completion (week 52 or at point of early termination). However, PSA DT will be determined starting at week 26 (the earliest time point with 3 values) and week 39 and recorded. PSA doubling time is a measure based on the slope of the PSA at multiple time points. If the slope is relatively flat, the predicted doubling time could be far beyond the length of the actual study. As such, the value is not limited to the time frame over which data is collected from the participant.

Prostate Specific Antigen Doubling Time (PSA DT)

Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core ("benign" in results), tumor tissue from a positive core ("tumor" in results), and normal tissue adjacent to tumor from a positive core ("adjacent" in results). Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.

Change in Tissue Biomarker Levels: PSA

Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core ("benign" in results), tumor tissue from a positive core ("tumor" in results), and normal tissue adjacent to tumor from a positive core ("adjacent" in results). Measurements for each are per nuclear ("Nuc" in results), cytoplasmic ("Cyt" in results), and cellular ("Cell" in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.

Change in Tissue Biomarker Levels: IGF-1

Change in Tissue Biomarker Levels: IGFBP-3

Change in Tissue Biomarker Levels: CASP3

Change in Tissue Biomarker Levels: Ki-67

Change in Tissue Biomarker Levels: IGF-Rb

Change in Tissue Biomarker Levels: 8OHdG

Change in Tissue Biomarker Levels: AR

Change in Levels of Pomegranate Fruit Extract (PFE) Constituents/Metabolites: Urolithin A

Change in Levels of PFE Constituents/Metabolites: Urolithin B

Change in Gleason Score

Change in the length of biopsy cores that contained cancerous tissue from Baseline to end of study.

Change in Biopsy Tumor Involvement on Prostate Biopsy

Overall Study

David Jarrard

PSA 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

Laboratory Biomarker Analysis

Pharmacological Study

Placebo

Pomegranate-Extract Pill

Lahey Hospital and Medical Center

University of Minnesota/Masonic Cancer Center

Urology San Antonio Research PA

University of Wisconsin Hospital and Clinics

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

urolithin a/рак

Pomegranate-Extract Pill in Preventing Tumor Growth in Patients With Localized Prostate Cancer Undergoing Active Surveillance

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