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.

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).

One participant has no compliance values for weeks 26 and 39.

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).

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.

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.

Statistician notes that serum PSA data is missing for one participant in the pomegranate extract arm for all time points, missing for another in the pomegranate arm at week 39, and one from the placebo arm at week 39.

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.

One of the participant's PSA values were 'non-detectable', therefore PSA observations could not be calculated for that participant.

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.

The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).

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.

The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).

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.

The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).

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.

The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).

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.

The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).

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.

The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).

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.

The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).

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.

The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).

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.

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.

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.

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

One participant has a baseline measurement but does not have an end of study measurement, a change in the biopsy tumor involvement for this participant is therefore not possible to calculate.