Trial Outcomes & Findings for Pomegranate-Extract Pill in Preventing Tumor Growth in Patients With Localized Prostate Cancer Undergoing Active Surveillance (NCT NCT02095145)
NCT ID: NCT02095145
Last Updated: 2020-02-05
Results Overview
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.
COMPLETED
PHASE2
38 participants
Baseline to 12 months
2020-02-05
Participant Flow
38 participants consented, only 30 eligible to start study
Participant milestones
| Measure |
Group I (Pomegranate-extract Pill)
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
|
Group II (Placebo)
Patients receive placebo orally once a day for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group I (Pomegranate-extract Pill)
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
|
Group II (Placebo)
Patients receive placebo orally once a day for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Pomegranate-Extract Pill in Preventing Tumor Growth in Patients With Localized Prostate Cancer Undergoing Active Surveillance
Baseline characteristics by cohort
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Participant Age · 18-64 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Customized
Participant Age · 65 years or older
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG 0
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG 1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Systolic Blood Pressure
|
140.71 mmHg
n=5 Participants
|
139.80 mmHg
n=7 Participants
|
140.24 mmHg
n=5 Participants
|
|
Diastolic Blood Pressure
|
81.64 mmHg
n=5 Participants
|
83.60 mmHg
n=7 Participants
|
82.66 mmHg
n=5 Participants
|
|
Temperature
|
97.81 degrees Fahrenheit
n=5 Participants
|
97.62 degrees Fahrenheit
n=7 Participants
|
97.71 degrees Fahrenheit
n=5 Participants
|
|
Pulse
|
75.00 beats per minute
n=5 Participants
|
68.13 beats per minute
n=7 Participants
|
71.45 beats per minute
n=5 Participants
|
|
Height
|
174.73 cm
n=5 Participants
|
177.23 cm
n=7 Participants
|
176.02 cm
n=5 Participants
|
|
Weight
|
88.92 kg
n=5 Participants
|
94.53 kg
n=7 Participants
|
91.82 kg
n=5 Participants
|
|
Body Mass Index
|
29.15 kg/m^2
n=5 Participants
|
29.91 kg/m^2
n=7 Participants
|
29.55 kg/m^2
n=5 Participants
|
|
History or Baseline Presence of Disease / Abnormality
Skin
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
History or Baseline Presence of Disease / Abnormality
Prostate
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
History or Baseline Presence of Disease / Abnormality
Head/Eyes/Ears/Neck/Throat
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
History or Baseline Presence of Disease / Abnormality
Neurological
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
History or Baseline Presence of Disease / Abnormality
Abdomen
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
History or Baseline Presence of Disease / Abnormality
Genitalia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gleason Score
3+3=6
|
13 scores on a scale
n=5 Participants
|
15 scores on a scale
n=7 Participants
|
28 scores on a scale
n=5 Participants
|
|
Gleason Score
3+4=7
|
1 scores on a scale
n=5 Participants
|
0 scores on a scale
n=7 Participants
|
1 scores on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsThe 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Plasma IGF-1 From Baseline to Post-Treatment
|
19.12 ng/mL
Standard Deviation 21.22
|
8.54 ng/mL
Standard Deviation 23.11
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: One participant has no compliance values for weeks 26 and 39.
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).
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Compliance: Number of Participants Who Took Study Drug Per Protocol
Week 26
|
14 Participants
|
14 Participants
|
|
Compliance: Number of Participants Who Took Study Drug Per Protocol
Week 39
|
14 Participants
|
14 Participants
|
|
Compliance: Number of Participants Who Took Study Drug Per Protocol
Week 13
|
14 Participants
|
14 Participants
|
|
Compliance: Number of Participants Who Took Study Drug Per Protocol
End of Study (Week 52)
|
14 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPatient 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).
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Incidence of Adverse Events Graded Per Common Terminology Criteria for Adverse Events (CTCAE)
Any Adverse Event
|
14 Participants
|
13 Participants
|
|
Incidence of Adverse Events Graded Per Common Terminology Criteria for Adverse Events (CTCAE)
Serious Adverse Events
|
2 Participants
|
2 Participants
|
|
Incidence of Adverse Events Graded Per Common Terminology Criteria for Adverse Events (CTCAE)
Multiple Adverse Events
|
14 Participants
|
11 Participants
|
|
Incidence of Adverse Events Graded Per Common Terminology Criteria for Adverse Events (CTCAE)
Grade 3 (Severe) or Worse
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 13, Week 26, Week 39, Week 52Differences 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Plasma Biomarker Levels From Baseline: IGFBP-3
Change Baseline to Week 13
|
-102.91 ng/mL
Standard Deviation 501.07
|
-195.57 ng/mL
Standard Deviation 592.17
|
|
Change in Plasma Biomarker Levels From Baseline: IGFBP-3
Change Baseline to Week 39
|
-309.11 ng/mL
Standard Deviation 455.91
|
89.34 ng/mL
Standard Deviation 381.47
|
|
Change in Plasma Biomarker Levels From Baseline: IGFBP-3
Change Baseline to Week 52
|
-137.67 ng/mL
Standard Deviation 363.48
|
-0.39 ng/mL
Standard Deviation 498.02
|
|
Change in Plasma Biomarker Levels From Baseline: IGFBP-3
Change Baseline to Week 26
|
10.55 ng/mL
Standard Deviation 560.69
|
99.74 ng/mL
Standard Deviation 652.11
|
SECONDARY outcome
Timeframe: Week 13, Week 26, Week 39, Week 52Differences 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Plasma Biomarker Levels From Baseline: IGF-1/GFBP-3
Change Baseline to Week 13
|
0.00 ratio
Standard Deviation 0.01
|
0.01 ratio
Standard Deviation 0.01
|
|
Change in Plasma Biomarker Levels From Baseline: IGF-1/GFBP-3
Change Baseline to Week 26
|
0.00 ratio
Standard Deviation 0.01
|
-0.00 ratio
Standard Deviation 0.01
|
|
Change in Plasma Biomarker Levels From Baseline: IGF-1/GFBP-3
Change Baseline to Week 39
|
0.01 ratio
Standard Deviation 0.01
|
-0.00 ratio
Standard Deviation 0.01
|
|
Change in Plasma Biomarker Levels From Baseline: IGF-1/GFBP-3
Change Baseline to Week 52
|
0.01 ratio
Standard Deviation 0.01
|
0.00 ratio
Standard Deviation 0.01
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Total Serum Prostate Specific Antigen (PSA) From Baseline
Change from Baseline Week 26
|
-1.41 ng/mL
Standard Deviation 4.67
|
-0.77 ng/mL
Standard Deviation 1.33
|
|
Change in Total Serum Prostate Specific Antigen (PSA) From Baseline
Change Baseline to Week 13
|
-1.88 ng/mL
Standard Deviation 4.78
|
-1.05 ng/mL
Standard Deviation 1.67
|
|
Change in Total Serum Prostate Specific Antigen (PSA) From Baseline
Change from Baseline Week 39
|
-1.52 ng/mL
Standard Deviation 5.52
|
-0.29 ng/mL
Standard Deviation 1.91
|
|
Change in Total Serum Prostate Specific Antigen (PSA) From Baseline
Change Baseline to Week 52
|
-1.00 ng/mL
Standard Deviation 5.89
|
-0.08 ng/mL
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: up to 1 yearOutcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Serum Testosterone
Baseline
|
9.37 pg/ml
Standard Deviation 5.23
|
9.73 pg/ml
Standard Deviation 3.03
|
|
Change in Serum Testosterone
Week 26
|
11.43 pg/ml
Standard Deviation 10.48
|
12.61 pg/ml
Standard Deviation 13.46
|
|
Change in Serum Testosterone
Week 52
|
14.83 pg/ml
Standard Deviation 19.84
|
9.27 pg/ml
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: up to 52 WeeksPopulation: One of the participant's PSA values were 'non-detectable', therefore PSA observations could not be calculated for that participant.
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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=13 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Prostate Specific Antigen Doubling Time (PSA DT)
|
134.01 weeks
Standard Deviation 560.33
|
125.63 weeks
Standard Deviation 282.90
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Tissue Biomarker Levels: PSA
Change From Baseline: Tumor
|
0.09 normalized optical density
Standard Deviation 0.39
|
0.25 normalized optical density
Standard Deviation 0.52
|
|
Change in Tissue Biomarker Levels: PSA
Change From Baseline: Benign
|
0.01 normalized optical density
Standard Deviation 0.42
|
0.04 normalized optical density
Standard Deviation 0.21
|
|
Change in Tissue Biomarker Levels: PSA
Change From Baseline: Adjacent
|
-0.10 normalized optical density
Standard Deviation 0.09
|
0.16 normalized optical density
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Tissue Biomarker Levels: IGF-1
Change From Baseline: Nuc Adjacent
|
-0.58 normalized optical density
Standard Deviation 2.78
|
1.74 normalized optical density
Standard Deviation 1.45
|
|
Change in Tissue Biomarker Levels: IGF-1
Change From Baseline: Nuc Benign
|
-0.10 normalized optical density
Standard Deviation 1.65
|
0.57 normalized optical density
Standard Deviation 1.91
|
|
Change in Tissue Biomarker Levels: IGF-1
Change From Baseline: Nuc Tumor
|
-0.53 normalized optical density
Standard Deviation 2.39
|
1.06 normalized optical density
Standard Deviation 1.41
|
|
Change in Tissue Biomarker Levels: IGF-1
Change From Baseline: Cyt Benign
|
-0.43 normalized optical density
Standard Deviation 1.35
|
0.21 normalized optical density
Standard Deviation 1.38
|
|
Change in Tissue Biomarker Levels: IGF-1
Change From Baseline: Cyt Adjacent
|
-0.52 normalized optical density
Standard Deviation 1.77
|
1.47 normalized optical density
Standard Deviation 1.15
|
|
Change in Tissue Biomarker Levels: IGF-1
Change From Baseline: Cyt Tumor
|
-0.65 normalized optical density
Standard Deviation 1.64
|
1.10 normalized optical density
Standard Deviation 1.01
|
|
Change in Tissue Biomarker Levels: IGF-1
Change From Baseline: Cell Benign
|
-0.29 normalized optical density
Standard Deviation 1.45
|
0.35 normalized optical density
Standard Deviation 1.58
|
|
Change in Tissue Biomarker Levels: IGF-1
Change From Baseline: Cell Adjacent
|
-0.53 normalized optical density
Standard Deviation 2.17
|
1.59 normalized optical density
Standard Deviation 1.18
|
|
Change in Tissue Biomarker Levels: IGF-1
Change From Baseline: Cell Tumor
|
-0.61 normalized optical density
Standard Deviation 1.99
|
1.06 normalized optical density
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Tissue Biomarker Levels: IGFBP-3
Change From Baseline: Nuc Benign
|
-0.43 normalized optical density
Standard Deviation 2.77
|
0.78 normalized optical density
Standard Deviation 3.70
|
|
Change in Tissue Biomarker Levels: IGFBP-3
Change From Baseline: Nuc Tumor
|
0.69 normalized optical density
Standard Deviation 2.21
|
1.75 normalized optical density
Standard Deviation 1.79
|
|
Change in Tissue Biomarker Levels: IGFBP-3
Change From Baseline: Cell Adjacent
|
-0.24 normalized optical density
Standard Deviation 1.62
|
1.07 normalized optical density
Standard Deviation 1.13
|
|
Change in Tissue Biomarker Levels: IGFBP-3
Change From Baseline: Nuc Adjacent
|
0.01 normalized optical density
Standard Deviation 1.51
|
1.55 normalized optical density
Standard Deviation 1.90
|
|
Change in Tissue Biomarker Levels: IGFBP-3
Change From Baseline: Cyt Benign
|
-0.38 normalized optical density
Standard Deviation 1.56
|
0.52 normalized optical density
Standard Deviation 1.26
|
|
Change in Tissue Biomarker Levels: IGFBP-3
Change From Baseline: Cyt Adjacent
|
-0.96 normalized optical density
Standard Deviation 1.39
|
0.67 normalized optical density
Standard Deviation 0.90
|
|
Change in Tissue Biomarker Levels: IGFBP-3
Change From Baseline: Cyt Tumor
|
-1.09 normalized optical density
Standard Deviation 0.90
|
0.76 normalized optical density
Standard Deviation 0.80
|
|
Change in Tissue Biomarker Levels: IGFBP-3
Change From Baseline: Cell Benign
|
-0.43 normalized optical density
Standard Deviation 2.02
|
0.68 normalized optical density
Standard Deviation 2.39
|
|
Change in Tissue Biomarker Levels: IGFBP-3
Change From Baseline: Cell Tumor
|
-0.14 normalized optical density
Standard Deviation 1.48
|
1.24 normalized optical density
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Tissue Biomarker Levels: CASP3
Change From Baseline: Nuc Tumor
|
-0.34 normalized optical density
Standard Deviation 1.06
|
0.04 normalized optical density
Standard Deviation 0.43
|
|
Change in Tissue Biomarker Levels: CASP3
Change From Baseline: Cell Adjacent
|
-0.40 normalized optical density
Standard Deviation 1.16
|
0.43 normalized optical density
Standard Deviation 1.42
|
|
Change in Tissue Biomarker Levels: CASP3
Change From Baseline: Nuc Benign
|
-0.61 normalized optical density
Standard Deviation 1.74
|
0.57 normalized optical density
Standard Deviation 1.74
|
|
Change in Tissue Biomarker Levels: CASP3
Change From Baseline: Nuc Adjacent
|
-0.40 normalized optical density
Standard Deviation 1.06
|
0.38 normalized optical density
Standard Deviation 1.55
|
|
Change in Tissue Biomarker Levels: CASP3
Change From Baseline: Cyt Benign
|
-0.49 normalized optical density
Standard Deviation 1.43
|
-0.01 normalized optical density
Standard Deviation 1.30
|
|
Change in Tissue Biomarker Levels: CASP3
Change From Baseline: Cyt Adjacent
|
-0.42 normalized optical density
Standard Deviation 1.31
|
0.54 normalized optical density
Standard Deviation 1.44
|
|
Change in Tissue Biomarker Levels: CASP3
Change From Baseline: Cyt Tumor
|
-0.45 normalized optical density
Standard Deviation 1.66
|
-0.00 normalized optical density
Standard Deviation 0.33
|
|
Change in Tissue Biomarker Levels: CASP3
Change From Baseline: Cell Benign
|
-0.54 normalized optical density
Standard Deviation 1.52
|
0.23 normalized optical density
Standard Deviation 1.40
|
|
Change in Tissue Biomarker Levels: CASP3
Change From Baseline: Cell Tumor
|
-0.35 normalized optical density
Standard Deviation 1.35
|
0.01 normalized optical density
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Tissue Biomarker Levels: Ki-67
Change From Baseline: Benign
|
0.01 percent change
Standard Deviation 0.50
|
0.06 percent change
Standard Deviation 0.52
|
|
Change in Tissue Biomarker Levels: Ki-67
Change From Baseline: Adjacent
|
-0.27 percent change
Standard Deviation 0.36
|
-0.53 percent change
Standard Deviation 1.73
|
|
Change in Tissue Biomarker Levels: Ki-67
Change From Baseline:Tumor
|
-6.40 percent change
Standard Deviation 12.11
|
1.31 percent change
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Tissue Biomarker Levels: IGF-Rb
Change From Baseline: Nuc Benign
|
-0.50 normalized optical density
Standard Deviation 1.08
|
-0.52 normalized optical density
Standard Deviation 1.03
|
|
Change in Tissue Biomarker Levels: IGF-Rb
Change From Baseline: Nuc Adjacent
|
0.62 normalized optical density
Standard Deviation 1.24
|
0.32 normalized optical density
Standard Deviation 0.37
|
|
Change in Tissue Biomarker Levels: IGF-Rb
Change From Baseline: Nuc Tumor
|
0.63 normalized optical density
Standard Deviation 2.00
|
0.88 normalized optical density
Standard Deviation 0.50
|
|
Change in Tissue Biomarker Levels: IGF-Rb
Change From Baseline: Cyt Benign
|
0.09 normalized optical density
Standard Deviation 1.35
|
-0.48 normalized optical density
Standard Deviation 1.19
|
|
Change in Tissue Biomarker Levels: IGF-Rb
Change From Baseline: Cyt Adjacent
|
-0.24 normalized optical density
Standard Deviation 0.71
|
0.80 normalized optical density
Standard Deviation 0.94
|
|
Change in Tissue Biomarker Levels: IGF-Rb
Change From Baseline: Cyt Tumor
|
0.04 normalized optical density
Standard Deviation 1.45
|
0.58 normalized optical density
Standard Deviation 0.42
|
|
Change in Tissue Biomarker Levels: IGF-Rb
Change From Baseline: Cell Benign
|
-0.19 normalized optical density
Standard Deviation 1.21
|
-0.52 normalized optical density
Standard Deviation 1.05
|
|
Change in Tissue Biomarker Levels: IGF-Rb
Change From Baseline: Cell Adjacent
|
0.17 normalized optical density
Standard Deviation 0.85
|
0.56 normalized optical density
Standard Deviation 0.52
|
|
Change in Tissue Biomarker Levels: IGF-Rb
Change From Baseline: Cell Tumor
|
0.31 normalized optical density
Standard Deviation 1.63
|
0.73 normalized optical density
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Tissue Biomarker Levels: 8OHdG
Change From Baseline: Nuc Benign
|
-0.05 normalized optical density
Standard Deviation 0.15
|
-0.02 normalized optical density
Standard Deviation 0.15
|
|
Change in Tissue Biomarker Levels: 8OHdG
Change From Baseline: Nuc Adjacent
|
-0.09 normalized optical density
Standard Deviation 0.13
|
0.07 normalized optical density
Standard Deviation 0.16
|
|
Change in Tissue Biomarker Levels: 8OHdG
Change From Baseline: Nuc Tumor
|
-0.15 normalized optical density
Standard Deviation 0.08
|
0.07 normalized optical density
Standard Deviation 0.20
|
|
Change in Tissue Biomarker Levels: 8OHdG
Change From Baseline: Cyt Benign
|
-0.15 normalized optical density
Standard Deviation 0.47
|
0.21 normalized optical density
Standard Deviation 0.54
|
|
Change in Tissue Biomarker Levels: 8OHdG
Change From Baseline: Cyt Adjacent
|
-0.28 normalized optical density
Standard Deviation 0.45
|
0.47 normalized optical density
Standard Deviation 0.54
|
|
Change in Tissue Biomarker Levels: 8OHdG
Change From Baseline: Cyt Tumor
|
-0.58 normalized optical density
Standard Deviation 0.33
|
0.41 normalized optical density
Standard Deviation 0.52
|
|
Change in Tissue Biomarker Levels: 8OHdG
Change From Baseline: Cell Benign
|
-0.17 normalized optical density
Standard Deviation 0.43
|
0.09 normalized optical density
Standard Deviation 0.39
|
|
Change in Tissue Biomarker Levels: 8OHdG
Change From Baseline: Cell Adjacent
|
-0.31 normalized optical density
Standard Deviation 0.43
|
0.20 normalized optical density
Standard Deviation 0.40
|
|
Change in Tissue Biomarker Levels: 8OHdG
Change From Baseline: Cell Tumor
|
-0.50 normalized optical density
Standard Deviation 0.28
|
0.19 normalized optical density
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Tissue Biomarker Levels: AR
Change From Baseline: Benign
|
0.48 normalized optical density
Standard Deviation 1.07
|
-0.55 normalized optical density
Standard Deviation 1.87
|
|
Change in Tissue Biomarker Levels: AR
Change From Baseline: Adjacent
|
-0.38 normalized optical density
Standard Deviation 0.60
|
1.02 normalized optical density
Standard Deviation 0.90
|
|
Change in Tissue Biomarker Levels: AR
Change From Baseline: Tumor
|
-1.22 normalized optical density
Standard Deviation 1.15
|
0.38 normalized optical density
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Change from Baseline at Week 13, Week 26, Week 39, and Week 52Differences 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Levels of Pomegranate Fruit Extract (PFE) Constituents/Metabolites: Urolithin A
Change from Baseline Week 13
|
13491.88 ng
Standard Deviation 25612.57
|
-8722.87 ng
Standard Deviation 32254.35
|
|
Change in Levels of Pomegranate Fruit Extract (PFE) Constituents/Metabolites: Urolithin A
Change from Baseline Week 26
|
29686.34 ng
Standard Deviation 38169.43
|
-7119.63 ng
Standard Deviation 33532.58
|
|
Change in Levels of Pomegranate Fruit Extract (PFE) Constituents/Metabolites: Urolithin A
Change from Baseline Week 39
|
41322.95 ng
Standard Deviation 80948.44
|
-3688.76 ng
Standard Deviation 32749.71
|
|
Change in Levels of Pomegranate Fruit Extract (PFE) Constituents/Metabolites: Urolithin A
Change from Baseline Week 52
|
21622.01 ng
Standard Deviation 29672.67
|
-4882.23 ng
Standard Deviation 17075.55
|
SECONDARY outcome
Timeframe: Change from Baseline at Week 13, Week 26, Week 39, and Week 52Differences 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Levels of PFE Constituents/Metabolites: Urolithin B
Change from Baseline Week 13
|
0.00 ng
Standard Deviation 0.00
|
0.00 ng
Standard Deviation 0.00
|
|
Change in Levels of PFE Constituents/Metabolites: Urolithin B
Change from Baseline Week 26
|
0.00 ng
Standard Deviation 0.00
|
156.86 ng
Standard Deviation 603.11
|
|
Change in Levels of PFE Constituents/Metabolites: Urolithin B
Change from Baseline Week 39
|
709.24 ng
Standard Deviation 2653.74
|
801.40 ng
Standard Deviation 2807.45
|
|
Change in Levels of PFE Constituents/Metabolites: Urolithin B
Change from Baseline Week 52
|
1389.82 ng
Standard Deviation 4536.11
|
216.54 ng
Standard Deviation 838.66
|
SECONDARY outcome
Timeframe: Baseline to 1 yearThe 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.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=14 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Gleason Score
Baseline · 0+0=0
|
0 Participants
|
0 Participants
|
|
Change in Gleason Score
Baseline · 3+3=6
|
13 Participants
|
15 Participants
|
|
Change in Gleason Score
Baseline · 3+4=7
|
1 Participants
|
0 Participants
|
|
Change in Gleason Score
Surgery Visit (52 Weeks) · 0+0=0
|
5 Participants
|
6 Participants
|
|
Change in Gleason Score
Surgery Visit (52 Weeks) · 3+3=6
|
7 Participants
|
8 Participants
|
|
Change in Gleason Score
Surgery Visit (52 Weeks) · 3+4=7
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 1 yearPopulation: 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.
Change in the length of biopsy cores that contained cancerous tissue from Baseline to end of study.
Outcome measures
| Measure |
Group I (Pomegranate-extract Pill)
n=13 Participants
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 II (Placebo)
n=15 Participants
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Change in Biopsy Tumor Involvement on Prostate Biopsy
|
0.34 mm
Standard Deviation 8.09
|
1.88 mm
Standard Deviation 8.36
|
Adverse Events
Group I (Pomegranate-extract Pill)
Group II (Placebo)
Serious adverse events
| Measure |
Group I (Pomegranate-extract Pill)
n=14 participants at risk
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 II (Placebo)
n=15 participants at risk
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Gastrointestinal disorders
Colitis
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Surgical and medical procedures
Surgical and Medical Procedures, other
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Surgical and medical procedures
Post-Operative Hemorrhage
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
Other adverse events
| Measure |
Group I (Pomegranate-extract Pill)
n=14 participants at risk
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 II (Placebo)
n=15 participants at risk
Patients receive placebo PO QD for 52 weeks (+/- 1 week).
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given PO
|
|---|---|---|
|
Gastrointestinal disorders
Colitis
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
21.4%
3/14 • Number of events 3 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
13.3%
2/15 • Number of events 2 • up to 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders, Other
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
13.3%
2/15 • Number of events 2 • up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Renal and urinary disorders
Cystitis Noninfective
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Renal and urinary disorders
Hematuria
|
14.3%
2/14 • Number of events 2 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Renal and urinary disorders
Renal and Urinary Disorders, Other
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
6.7%
1/15 • Number of events 2 • up to 52 weeks
|
|
Renal and urinary disorders
Renal Calculi
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Renal and urinary disorders
Urinary Retention
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Renal and urinary disorders
Urinary Tract Pain
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Renal and urinary disorders
Urinary Urgency
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Nervous system disorders
Sinus Pain
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
2/14 • Number of events 4 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased Lumbar Spine
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
20.0%
3/15 • Number of events 3 • up to 52 weeks
|
|
Investigations
Cholesterol High
|
14.3%
2/14 • Number of events 2 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Investigations
Creatinine Increased
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Injury, poisoning and procedural complications
Post-Operative Hemorrhage
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Infections and infestations
Skin Infection
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Infections and infestations
Tooth Infection
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
14.3%
2/14 • Number of events 4 • up to 52 weeks
|
20.0%
3/15 • Number of events 5 • up to 52 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
General disorders
Fever
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
General disorders
Malaise
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
6.7%
1/15 • Number of events 2 • up to 52 weeks
|
|
Vascular disorders
Hematoma
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Infections and infestations
Infections and Infestations, Other
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Surgical and medical procedures
Surgical and Medical Procedures
|
14.3%
2/14 • Number of events 2 • up to 52 weeks
|
26.7%
4/15 • Number of events 12 • up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
2/14 • Number of events 2 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
7.1%
1/14 • Number of events 2 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 2 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Cardiac disorders
Cardiac Disorders, other
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Injury, poisoning and procedural complications
Burn
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Investigations
Investigations, other
|
7.1%
1/14 • Number of events 2 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • up to 52 weeks
|
13.3%
2/15 • Number of events 2 • up to 52 weeks
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
7.1%
1/14 • Number of events 2 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Eye disorders
Eye Disorders, Other
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Immune system disorders
Allergic Reaction
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 2 • up to 52 weeks
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System, other
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Vascular disorders
Hypertension
|
71.4%
10/14 • Number of events 18 • up to 52 weeks
|
53.3%
8/15 • Number of events 16 • up to 52 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14 • up to 52 weeks
|
6.7%
1/15 • Number of events 1 • up to 52 weeks
|
|
Cardiac disorders
Sinus Bradycardia
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
|
Cardiac disorders
Sinus Tachycardia
|
7.1%
1/14 • Number of events 1 • up to 52 weeks
|
0.00%
0/15 • up to 52 weeks
|
Additional Information
David Jarrard
University of Wisconsin Carbone Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60