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Q-CAN® Plus Fermented Soy ("QC") vs Control FINAL Statistical Report Table of Contents

Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
Q-CAN® Plus Fermented Soy ("QC") vs
Control
FINAL Statistical Report
Table of Contents
Report Summary
Figure 1: Study Consort Diagram
A. Summary of Participant Disposition
B. Enrollment, Randomization and Baseline Characteristics
1. Enrollment Plot
2. Randomization by Intervention
3. Baseline Demographic Characteristics
4. Fidelity and acceptability of intervention over time
C. Follow-up
1. Completeness of follow-up OnCore assessments: Observed/Expected
2. Primary Outcome Assessment completeness
D. Outcomes
Primary Outcome
1. Primary Outcome Bivariate Analysis: PSA
2. Primary Outcome Bivariate Analysis: PSA, Stratified by CAPRA Risk
3. Primary Outcome: Intention to Treat (ITT) BY Risk
4. Primary Outcome: (ITT)
5. Regression Analyses
a. Primary Outcome: As Treated
b. Primary Outcome: As Treated; By Risk
Secondary Outcomes
1. Summary of Secondary Outcomes
E. Safety
1. Adverse events: overall, reported during follow-up
2. Serious Adverse events: overall, reported during follow-up
1 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
Figure 1: Study Consort Diagram
Recruitment start date: 08/02/2018
Recruitment end date: 12/04/2019
*One patient was randomized but never received intervention.
**Two patients’ final assessments were not fully processed by the lab.
Screened for Study (n=25)

QC (n=10)

Allocation

Randomized
(n=19)

Enrollment

Placebo (n=9)

Completed Study
(Week 3, n=10)
Completed Assessment on
Primary Outcome
(Week 3, n=9**)
Completed Study
(Week 3, n=8*)
Completed Assessment on
Primary Outcome
(Week 3, n=7**)
Assessment at up to 5 weeks
Eligible: Accepted (n=19)
Eligible: Declined (n=5)
Ineligible (n=1)
2 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
Report Summary
The following is the report summary for the study of Q-CAN® Plus Fermented Soy
("QC") vs Control. This report summarizes: enrollment and participant disposition,
baseline characteristics, follow up details, a summary of primary and secondary
outcomes and the assessment of participant safety with respect to adverse events. The study
was terminated due to low enrollment after 19 participants had been enrolled and randomized.
Between the recruitment start date of August 2, 2018 and the closure of the study related
patient follow up, December 4, 2019, 25 patients were assessed for eligibility for the study.
Of those 25, 24 patients were found to be eligible and 1 patient was deemed ineligible
due to anticoagulant use. Of those 24 patients found eligible for the study, 19 accepted
invitation to the study, while 5 declined to participate. The 19 patients were enrolled and
randomized to one of two blinded study arms (QC vs. placebo) across 2 sites (Table 1). One
patient in the placebo arm was randomized but never received the intervention. The final number
enrolled and randomized participants (19) is 26% of the anticipated accrual benchmark of 72
participants.
Of the 19 participants, 16 (84%) were assessed for the final measurement of primary outcome
measure: PSA. The reasons cited for missing the final assessment include: patient ineligibility
(n=1) and follow up lab data were not available (n=2). With respect to adherence to the
intervention (study drug use) and assessment (meeting study appointments), 90% of the
participants were more than 90% adherent with respect to both adherence measures.
Participants in the study were approximately 61 years old (SD=6, median=60 y). Those in the
study were mostly white (79%) and non-Hispanic (95%). The majority of men in the study listed
their current marital status as either married or cohabitating (79%). With respect to study sites,
more participants were from Lawrence and Memorial Hospital (58%) compared to Yale
University (42%). The aforementioned information and other demographic characteristics are
presented in Table 1. The distribution of the characteristics does not appear to meaningfully
differ between the 2 treatment arms in the study.
Table 2 presents a summary of the clinical endpoints in the study for all participants. There
were no significant differences found between the treatment arms with respect to these
measures. With respect to the change in CAPRA score at end of study, the study completers in
the Daily QC group (n=8) had a decrease of -1.25 (SD=0.89) and the Placebo group also had a
reduction in score (mean=-1.38, SD=1.30, n=8). The difference between these mean changes in
score were not found to be statistically significant (diff=0.13, 95% CI = -1.07, 1.32).
Table 3 presents a summary of the of quality of life measures. With respect to the changes in
quality of life from baseline at end of study, there were no difference of note between
treatment arms. There an increase in the FACT-P Total Score in the Daily QC arm (mean=4.50,
SD=11.11, n=10) and a decrease in the FACT-P Total Score in the Placebo arm (mean=-4.88,
SD=9.78, n=8). The difference between these mean changes in score were not found to be
statistically significant (diff=9.38, 95% CI = -1.22, 19.98).
3 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
Tables 4 and 5 present summaries of the other clinical endpoints (secondary outcomes)
collected as part of the study. Presented are the summary of these scores at baseline, end of
study/treatment and the difference between these scores on those with measures at both time
points (per protocol analysis). Across these measures, there were no significant differences
found.
The analysis of the primary outcome is summarized in Section D. Presented is the initial
comparison of PSA at baseline, end of study and then the difference of matched cases
(participants with both baseline and follow up data). The analyses found no significant
differences between the QC and placebo treatment arms at either time point or when
considering the change in PSA from baseline. The analysis was repeated by stratifying the
treatment arms by CAPRA risk and comparing the subgroups (Low/Moderate and High
respectively). These stratified analyses did not yield significant results, although it could be
suggested that the High Risk patients did differ with respect to PSA improvement where the QC
treatment arm improved and the placebo arm remained relatively unchanged (p = 0.17).
The intention to treat (ITT) analysis comparing PSA at end of study between the Daily QC group
to Placebo was conducted using a linear mixed model analysis using baseline CAPRA risk in the
model. This analysis determined that there were no significant differences found between the
treatment arms (p = 0.76). Of note, CAPRA risk was found to be statistically significant when
included in this model (p = 0.04).
When CAPRA risk was removed from the model, there were no significant differences between
treatment groups (p = 0.87), nor was there significant interaction between time and treatment
(p = 0.29). These findings indicate that the changes in PSA from baseline in both treatment arms
did not significantly differ when CAPRA risk was not included in the model.
The secondary analysis of the primary outcome was performed using the generalized linear
model where the final PSA measurement was assessed between treatment groups while
including the baseline PSA value in the statistical model. There were no significant differences
found between the treatment groups with respect to PSA (p = 0.31). In this model, baseline PSA
was found to be statistically significant (p < 0.01). However, further analyses of the baseline PSA
values found no discernible differences between treatment groups when considering baseline
PSA in between treatment groups. When these analyses were repeated with the inclusion of
the baseline CAPRA risk score in the model, no statistically significant differences were found (p
= 0.34).
Section E. presents the safety reporting summary. With respect to adverse events, there were
very few reported. There were 5 reported adverse events amongst 4 participants in the study.
Of those, only 1 event (rash) could possibly be attributed to the intervention. One patient
presented at the emergency department with unrelated symptoms, which led to a diagnosis of
enlarging aortic aneurysm and pneumonia. Because this event required a medical intervention,
it is also categorized as a serious adverse event.
4 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
A. Summary of Participant Disposition

QC	Placebo	Total
Enrolled/Randomized	10	9	19
Withdrew	2	1	3
Eligibility Protocol Deviations	0	0	0
Follow-up	8	8	16
Study Status
Completed Baseline visit	10	9	19
Completed Final Assessment (prior to Prostatectomy)	9	7	16

B. Enrollment, Randomization and Baseline
1. Enrollment plot
5 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
2. Randomization: By intervention

Study Site
Lawrence & Memorial Hospital	05 (50.00%)	06 (66.67%)	11 (57.89%)
Yale University	05 (50.00%)	03 (33.33%)	08 (42.11%)
Total	10	9	19

3. Baseline Demographic Characteristics
a. See Table 1. Demographics
4. Fidelity and acceptability of intervention over time
a. Adherence and assessment of intervention over time

QC n (%)	Placebo n (%)	Total n (%)
Adherence to Intervention <50% 50%-75% >75%-90% >90%	0 1 (10) 0 9 (90)	1 (11) 0 0 8 (89)	1 (5) 1 (5) 0 17 (90)
Adherence Assessment <50% 50%-75% 75%-90% >90%	0 1 (10) 0 9 (90)	1 (11) 0 0 8 (89)	1 (5) 1 (5) 0 17 (90)

Note: Percent adherence is calculated using data from all Weeks of Follow-up (range 1-5)
QC Adherence = (Observed Days of QC use/Expected Days of QC use)
Note: Percent assessment is calculated using data from all Weeks of Follow-up (range 1-5)
Assessment % = (Observed Assessments/Expected Assessments)
6 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
b. Adherence and assessment of intervention over time

Week	QC	Placebo
adherence	adherence
<50%	50- 75%	>75- 90%	>90%	Total	<50%	50- 75%	>75- 90%	>90%	Total
1	n	0	1	0	9	10	0	0	2	6	8
%	0	2.7	0	24.3	100	0	0	7.7	23.1	89.9
2	n	0	0	0	10	10	0	1	1	6	8
%	0	0	0	27.0	100	0	3.9	3.9	23.1	89.9
3	n	1	0	0	8	9	0	0	0	7	7
%	2.7	0	0	21.6	100	0	0	0	26.9	100
4	n	1	0	0	5	6	0	0	0	2	2
%	2.7	0	0	13.5	100	0	0	0	7.7	100
5	n	0	0	0	2	2	0	0	0	1	1
%	0	0	0	5.4	100	0	0	0	3.9	100
Total	n	2	1	0	34	0	1	3	22
%	5.4	2.7	0	91.9	0	3.9	11.5	84.6

Adherence = (1 – N drinks missed / 14) * 100
7 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
C. Follow-up
1. Completeness of follow-up assessments:

Timeframe	QC	Placebo
Baseline	10	9
Week 1	10	8
Week 2	10	8
Week 3	9	7
Week 4	6	2
Week 5	2	1

2. Primary outcome assessment completeness stratified by Baseline CAPRA Score

QC	Placebo	Total
Baseline
0-4: Low/Intermediate risk	5	5	10
5-10: High risk	5	4	9
Total	10	9	19 (100%)
Final Assessment
0-4: Low/Intermediate risk	5	4	9
5-10: High risk	4	3	7
Total	9	7	16 (84.2%)

% is of those randomized
8 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
D. Outcomes
1. Primary Outcome Bivariate Analysis: PSA

Treatment
QC	Placebo	Total	P Value
Baseline
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (SD)	8.98 (4.07)	8.66 (2.71)	8.83 (3.40)	0.85
Mean (95% CL)	8.98 (6.07 – 11.89)	8.66 (6.58 – 10.74)	8.83 (7.19 – 10.47)	0.85
Median (Range)	9.3 (2.3 – 15.3)	8.2 (5.1 – 12.7)	8.7 (2.3 – 15.3)	0.9
End of Study
N (N Missing)	9 (1)	7 (2)	16 (3)
Mean (SD)	8.02 (3.99)	9.53 (3.03)	8.68 (3.57)	0.42
Mean (95% CL)	8.02 (4.96 – 11.09)	9.53 (6.73 – 12.33)	8.68 (6.78 – 10.59)	0.42
Median (Range)	8.0 (1.7 – 15.9)	10.8 (4.5 – 12.7)	8.5 (1.7 – 15.9)	0.34
Difference (Baseline – End of Study)
N (N Missing)	9 (1)	7 (2)	16 (3)
Mean (SD)	0.85 (2.42)	-0.13 (1.43)	0.42 (2.05)	0.36
Mean (95% CL)	0.85 (-1.01 – 2.71)	-0.13 (-1.46 – 1.19)	0.42 (-0.67 – 1.51)	0.36
Median (Range)	0.6 (-2.8 – 5.2)	-0.1 (-2.5 – 2.1)	0.4 (-2.8 – 5.2)	0.4

9 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
2. Primary Outcome Bivariate Analysis: PSA, Stratified by CAPRA Risk

Treatment
QC	Placebo	Total	P Value
Low Risk
Baseline
N (N Missing)	5 (0)	5 (0)	10 (0)
Mean (SD)	6.26 (3.34)	8.08 (2.72)	7.17 (3.03)	0.37
Mean (95% CL)	6.26 (2.11 – 10.41)	8.08 (4.70 – 11.45)	7.17 (5.00 – 9.33)	0.37
Median (Range)	5.4 (2.3 – 10.6)	7.0 (5.8 – 12.7)	6.8 (2.3 – 12.7)	0.4
End of Study
N (N Missing)	5 (0)	4 (1)	9 (1)
Mean (SD)	6.50 (3.63)	8.07 (3.30)	7.20 (3.37)	0.53
Mean (95% CL)	6.50 (2.00 – 11.01)	8.07 (2.82 – 13.31)	7.20 (4.61 – 9.79)	0.53
Median (Range)	7.2 (1.7 – 10.1)	7.7 (4.5 – 12.4)	7.2 (1.7 – 12.4)	0.71
Difference (Baseline – End of Study)
N (N Missing)	5 (0)	4 (1)	9 (1)
Mean (SD)	-0.24 (1.70)	0.27 (1.38)	-0.02 (1.49)	0.64
Mean (95% CL)	-0.24 (-2.35 – 1.87)	0.27 (-1.93 – 2.47)	-0.02 (-1.16 – 1.13)	0.64
Median (Range)	0.5 (-2.8 – 1.5)	0.1 (-1.2 – 2.1)	0.3 (-2.8 – 2.1)	1
High Risk
Baseline
N (N Missing)	5 (0)	4 (0)	9 (0)
Mean (SD)	11.69 (2.76)	9.40 (2.90)	10.67 (2.90)	0.26
Mean (95% CL)	11.69 (8.27 – 15.12)	9.40 (4.78 – 14.01)	10.67 (8.44 – 12.90)	0.26
Median (Range)	10.8 (8.6 – 15.3)	10.5 (5.1 – 11.5)	10.7 (5.1 – 15.3)	0.54
End of Study
N (N Missing)	4 (1)	3 (1)	7 (2)
Mean (SD)	9.92 (4.03)	11.49 (1.07)	10.59 (3.04)	0.55
Mean (95% CL)	9.92 (3.51 – 16.34)	11.49 (8.82 – 14.16)	10.59 (7.79 – 13.40)	0.55
Median (Range)	8.3 (7.2 – 15.9)	10.9 (10.8 – 12.7)	10.8 (7.2 – 15.9)	0.38
Difference (Baseline – End of Study)
N (N Missing)	4 (1)	3 (1)	7 (2)
Mean (SD)	2.21 (2.71)	-0.67 (1.59)	0.97 (2.62)	0.17
Mean (95% CL)	2.21 (-2.10 – 6.51)	-0.67 (-4.61 – 3.27)	0.97 (-1.45 – 3.40)	0.17
Median (Range)	2.1 (-0.6 – 5.2)	-0.1 (-2.5 – 0.6)	0.6 (-2.5 – 5.2)	0.22

10 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
3. Primary Outcome: Intention to Treat BY CAPRA Risk

Treatment
Time	QC	Placebo
Least squares mean (standard error) of PSA
Baseline	8.97 (0.99)	8.83 (1.05)
End of Study	8.14 (1.01)	9.14 (1.10)
Analysis: Repeated Measures ANOVA using Linear Mixed Models Type 3 Tests of Effects p values indicate the significance level of the main effects and interaction terms in the statistical model. Treatment: p = 0.76; Time: p = 0.61; CAPRA Risk: p = 0.04; Time*Treatment: p = 0.29

4. Primary Outcome: Intention to Treat

Treatment
Time	QC	Placebo
Least squares mean (standard error) of PSA
Baseline	8.97 (1.10)	8.66 (1.16)
End of Study	8.11 (1.12)	8.92 (1.21)
Analysis: Repeated Measures ANOVA using Linear Mixed Models Type 3 Tests of Effects p values indicate the significance level of the main effects and interaction terms in the statistical model. Treatment: p = 0.87; Time: p = 0.56; Time*Treatment: p = 0.29

11 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
5. Regression analyses
a. Primary Outcome: As Treated

Treatment
Time	QC	Placebo
Least squares mean (standard error) of PSA
End of Study	8.21 (0.68)	9.28 (0.77)
Analysis: ANCOVA using the General Linear Model Parameter estimates p values indicate the significance level of the covariates in the statistical model. Treatment: p = 0.31; PSA Baseline: p < 0.01

b. Primary Outcome: As Treated; By CAPRA Risk

Treatment
Time	QC	Placebo
Least squares mean (standard error) of PSA
End of Study	8.20 (0.70)	9.24 (0.80)
Analysis: ANCOVA using the General Linear Model Parameter estimates p values indicate the significance level of the covariates in the statistical model. Treatment: p = 0.31; PSA Baseline: p < 0.01; CAPRA Risk: p = 0.79

6. Summary of Secondary Outcomes
• See Summary Tables 2 thru 5.
 Note: Total Genistein Plasma Concentration was never collected for analysis
 Note: Telomere Length and Cell Cycle Progression Score Prostate Cancer mRNA
were never processed due to early termination.
12 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Report Creation: 16JAN2020
E. Safety
1. Adverse events: Overall, reported during follow-up

Event name	QC (n events, n patients)	Placebo (n events, n patients)	Total (n events, n patients)
Rash	(1, 1)	(0, 0)	(1, 1)
Aortic Aneurysm and Pneumonia*	(1, 1)	(0, 0)	(1, 1)
Nausea / Dizzyness	(1, 1)	(0, 0)	(1, 1)
Atrial Fibrillation	(1, 1)	(1, 1)	(2, 2)
Number of unique participants with AE	(4, 3)	(1, 1)	(5, 4)
AE led to study discontinuation	0	0	0
* Also listed in Serious Adverse Event Table, event was presented at the ER.

2. Serious Adverse events: Overall, reported during follow-up

Event name	QC (n events, n patients)	Placebo (n events, n patients)	Total (n events, n patients)
Fatal	0	0	0
Life-threatening	0	0	0
Required hospitalization	(1, 1)	0	(1, 1)
Resulted in persistent or significant disability/incapacity	0	0	0
Considered serious by investigator	0	0	0
Number of unique participants with SAE	(1, 1)	0	(1, 1)
SAE led to study discontinuation	0	0	0

13 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 1: Summary of Baseline Characteristics
Characteristic Daily QC (n=10) Placebo (n=9) Total (n=19) Difference (95% CI)

Age at On Study (years) Mean (95% CL)	60.60 (55.66 , 65.54)	62.89 (57.95 , 67.83)	61.68 (58.50 , 64.87)	2.28 (-8.77 , 4.19)
Mean (SD)	60.60 (6.90)	62.89 (6.43)	61.68 (6.60)
Median (IQR)	60.5 (58.0 – 66.0)	60.0 (58.0 – 69.0)	60.0 (58.0 – 69.0)
Education (years)
Mean (95% CL)	12.60 (11.42 , 13.78)	14.11 (12.76 , 15.47)	13.32 (12.44 , 14.20)	1.51 (-3.16 , 0.14)
Mean (SD)	12.60 (1.65)	14.11 (1.76)	13.32 (1.83)
Median (IQR)	12.0 (12.0 – 14.0)	14.0 (12.0 – 16.0)	12.0 (12.0 – 15.0)
Gender
Male	10 (100.00%)	9 (100.00%)	19 (100.00%)	--
Race
Black or African American	2 (20.00%)	2 (22.22%)	4 (21.05%)	- 2% (-45%, 49%)
White	8 (80.00%)	7 (77.78%)	15 (78.95%)	2% (-49%, 45%)
Ethnicity
Hispanic or Latino	1 (10.00%)	0 (00.00%)	1 (5.26%)	10% (-39%, 19%)
Non-Hispanic	9 (90.00%)	9 (100.00%)	18 (94.74%)	-10% (-19%, 39%)
Site
Lawrence & Memorial Hospital	5 (50.00%)	6 (66.67%)	11 (57.89%)	-16% (-37%, 70%)
Yale University	5 (50.00%)	3 (33.33%)	8 (42.11%)	17% (-70%, 37%)
Current marital status
Married or Cohabiting	7 (70.00%)	8 (88.89%)	15 (78.95%)	-19% (-26%, 64%)
Not married/cohabitating	3 (30.00%)	1 (11.11%)	2 (10.53%)	19% (-64%, 26%)

Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 1 of 1
14 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 2: Summary of Clinical Endpoints
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 1 of 3

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Gleason score of the biopsy (primary/secondary)
No pattern 4 or 5	0 (00.00%)	1 (11.11%)	1 (5.26%)	-11% (-31%, 9%)
Primary pattern 4 or 5	6 (60.00%)	6 (66.67%)	12 (63.16%)	-7% (-49%, 36%)
Secondary pattern 4 or 5	4 (40.00%)	2 (22.22%)	6 (31.58%)	18% (-22%, 59%)
Missing	0 (00.00%)	0 (00.00%)	0 (00.00%)
Gleason score
3+4 (Prognosis = Good)	7 (87.50%)	5 (62.50%)	12 (75.00%)	25% (-16%, 65%)
4+3 (Prognosis = Likely to Spread)	0 (00.00%)	2 (25.00%)	2 (12.50%)	-25% (-56%, 6%)
8 - 10 (Prognosis = Likely to Spread Rapidly)	1 (12.50%)	1 (12.50%)	2 (12.50%)	0% (-34%, 34%)
Missing	2 (20.00%)	1 (11.11%)	3 (15.79%)
Clinical stage (T-stage)
T1 or T2	10 (100.00%)	9 (100.00%)	19 (100.00%)	--
Missing	00 (000.00%)	0 (00.00%)	00 (000.00%)
Percent of biopsy cores involved with cancer (positive for cancer)
< 34% (low)	5 (50.00%)	5 (55.56%)	10 (52.63%)	-6% (-50%, 39%)
>= 34% (high)	5 (50.00%)	4 (44.44%)	09 (47.37%)	6% (-39%, 50%)
Missing	00 (000.00%)	0 (00.00%)	00 (000.00%)
Surgical Margins (SM)
Negative	6 (75.00%)	8 (100.00%)	14 (87.50%)	-25% (-55% - 5%)
Positive	2 (25.00%)	0 (000.00%)	2 (12.50%)	25% (-5% - 55%)
Missing	2 (20.00%)	1 (11.11%)	3 (15.79%)

15 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 2: Summary of Clinical Endpoints
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 2 of 3

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Extracapsular Extension (ECE)
No	6 (75.00%)	5 (62.50%)	11 (68.75%)	13% (-32% - 58%)
Yes	2 (25.00%)	3 (37.50%)	5 (31.25%)	-13% (- 58% -32%)
Missing	2 (20.00%)	1 (11.11%)	3 (15.79%)
Lymph Node Invasion (LNI)
No	8 (100.00%)	8 (100.00%)	16 (100.00%)	--
Missing	2 (20.00%)	1 (11.11%)	3 (15.79%)
Seminal Vesicle Invasions (SVI)
No	8 (100.00%)	7 (87.50%)	15 (93.75%)	13% (-10% - 35%)
Yes	0 (00.00%)	1 (12.50%)	1 (6.25%)	-13% (-35% - 10%)
Missing	2 (20.00%)	1 (11.11%)	3 (15.79%)
CAPRA at Dx Score
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	4.40 (3.38 , 5.42)	4.33 (2.95 , 5.72)	4.37 (3.61 , 5.13)	0.07 (-1.50 , 1.63)
Mean (SD)	4.40 (1.43)	4.33 (1.80)	4.37 (1.57)
Median (IQR)	4.5 (3.0 – 5.0)	4.0 (3.0 – 6.0)	4.0 (3.0 – 6.0)

16 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 2: Summary of Clinical Endpoints
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 3 of 3

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
CAPRA End of Study Score
N (N Missing)	8 (2)	8 (1)	16 (3)
Mean (95% CL)	2.75 (1.35 , 4.15)	2.75 (0.98 , 4.52)	2.75 (1.77 , 3.73)	0.00 (-2.04 , 2.04)
Mean (SD)	2.75 (1.67)	2.75 (2.12)	2.75 (1.84)
Median (IQR)	2.0 (1.5 – 4.5)	2.0 (1.0 – 4.0)	2.0 (1.0 – 4.0)
Difference CAPRA Score
N (N Missing)	8 (2)	8 (1)	16 (3)
Mean (95% CL)	-1.25 (-1.99 , -0.51)	-1.38 (-2.46 , -0.29)	-1.31 (-1.89 , -0.74)	0.13 (-1.07 , 1.32)
Mean (SD)	-1.25 (0.89)	-1.38 (1.30)	-1.31 (1.08)
Median (IQR)	-1.5 (-2.0 – -0.5)	-1.0 (-2.5 – -1.0)	-1.0 (-2.0 – -1.0)

17 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 3: Summary of Quality of Life Measures
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 1 of 6

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline FACT-P Total Score
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	121.50 (104.47 , 138.53)	128.44 (118.07 , 138.82)	124.79 (115.43 , 134.15)	-6.94 (-25.98 , 12.09)
Mean (SD)	121.50 (23.81)	128.44 (13.49)	124.79 (19.42)
Median (IQR)	129.5 (103.0 – 140.0)	131.0 (114.0 – 137.0)	131.0 (113.0 – 140.0)
End of Study FACT-P Total Score
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	126.00 (113.04 , 138.96)	123.25 (112.79 , 133.71)	124.78 (117.07 , 132.49)	2.75 (-13.25 , 18.75)
Mean (SD)	126.00 (18.12)	123.25 (12.51)	124.78 (15.50)
Median (IQR)	128.5 (111.0 – 140.0)	123.0 (117.0 – 132.5)	124.5 (116.0 – 139.0)
Difference FACT-P Total Score
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	4.50 (-3.45 , 12.45)	-4.88 (-13.05 , 3.30)	0.33 (-5.29 , 5.95)	9.38 (-1.22 , 19.98)
Mean (SD)	4.50 (11.11)	-4.88 (9.78)	0.33 (11.30)
Median (IQR)	2.0 (-4.0 – 8.0)	-7.5 (-11.0 – -1.0)	-2.0 (-7.0 – 8.0)

18 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 3: Summary of Quality of Life Measures
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 2 of 6

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline PWB Subscore
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	23.60 (19.17 , 28.03)	25.67 (23.82 , 27.51)	24.58 (22.28 , 26.88)	-2.07 (-6.73 , 2.58)
Mean (SD)	23.60 (6.19)	25.67 (2.40)	24.58 (4.78)
Median (IQR)	26.5 (23.0 – 28.0)	26.0 (25.0 – 28.0)	26.0 (23.0 – 28.0)
End of Study PWB Subscore
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	25.40 (22.22 , 28.58)	27.13 (26.18 , 28.07)	26.17 (24.46 , 27.87)	-1.72 (-5.17 , 1.71)
Mean (SD)	25.40 (4.45)	27.13 (1.13)	26.17 (3.43)
Median (IQR)	28.0 (25.0 – 28.0)	27.5 (26.5 – 28.0)	28.0 (26.0 – 28.0)
Difference PWB Subscore
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	1.80 (-0.85 , 4.45)	1.75 (-0.08 , 3.58)	1.78 (0.27 , 3.29)	0.05 (-3.10 , 3.20)
Mean (SD)	1.80 (3.71)	1.75 (2.19)	1.78 (3.04)
Median (IQR)	0.5 (0.0 – 2.0)	1.0 (0.0 – 3.0)	1.0 (0.0 – 2.0)

19 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 3: Summary of Quality of Life Measures
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 3 of 6

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline SWB Subscore
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	22.50 (19.14 , 25.86)	24.00 (21.15 , 26.85)	23.21 (21.18 , 25.24)	-1.50 (-5.62 , 2.63)
Mean (SD)	22.50 (4.70)	24.00 (3.71)	23.21 (4.21)
Median (IQR)	23.0 (22.0 – 27.0)	25.0 (20.0 – 27.0)	24.0 (20.0 – 27.0)
End of Study SWB Subscore
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	23.70 (21.46 , 25.94)	22.50 (19.10 , 25.90)	23.17 (21.42 , 24.92)	1.20 (-2.39 , 4.79)
Mean (SD)	23.70 (3.13)	22.50 (4.07)	23.17 (3.52)
Median (IQR)	24.5 (21.0 – 26.0)	24.0 (20.5 – 24.0)	24.0 (21.0 – 26.0)
Difference SWB Subscore
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	1.20 (-0.48 , 2.88)	-1.13 (-3.19 , 0.94)	0.17 (-1.14 , 1.47)	2.32 (-0.09 , 4.74)
Mean (SD)	1.20 (2.35)	-1.13 (2.47)	0.17 (2.62)
Median (IQR)	0.0 (0.0 – 3.0)	-1.0 (-3.0 – -0.5)	0.0 (-1.0 – 1.0)

20 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 3: Summary of Quality of Life Measures
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 4 of 6

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline EWB Subscore
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	19.20 (16.75 , 21.65)	18.78 (16.58 , 20.98)	19.00 (17.51 , 20.49)	0.42 (-2.65 , 3.50)
Mean (SD)	19.20 (3.43)	18.78 (2.86)	19.00 (3.09)
Median (IQR)	19.0 (17.0 – 21.0)	19.0 (18.0 – 20.0)	19.0 (17.0 – 21.0)
End of Study EWB Subscore
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	20.20 (17.70 , 22.70)	18.38 (15.45 , 21.30)	19.39 (17.64 , 21.14)	1.82 (-1.69 , 5.34)
Mean (SD)	20.20 (3.49)	18.38 (3.50)	19.39 (3.52)
Median (IQR)	20.0 (17.0 – 24.0)	18.5 (16.0 – 21.0)	18.5 (17.0 – 23.0)
Difference EWB Subscore
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	1.00 (-1.13 , 3.13)	-0.50 (-2.55 , 1.55)	0.33 (-1.05 , 1.72)	1.50 (-1.28 , 4.28)
Mean (SD)	1.00 (2.98)	-0.50 (2.45)	0.33 (2.79)
Median (IQR)	1.0 (0.0 – 2.0)	0.0 (-1.0 – 1.0)	0.5 (0.0 – 1.0)

21 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 3: Summary of Quality of Life Measures
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 5 of 6

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline FWB Subscore
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	22.30 (18.96 , 25.64)	22.89 (20.63 , 25.14)	22.58 (20.72 , 24.43)	-0.59 (-4.42 , 3.24)
Mean (SD)	22.30 (4.67)	22.89 (2.93)	22.58 (3.85)
Median (IQR)	23.5 (18.0 – 26.0)	23.0 (21.0 – 25.0)	23.0 (20.0 – 26.0)
End of Study FWB Subscore
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	21.30 (17.61 , 24.99)	21.00 (17.03 , 24.97)	21.17 (18.76 , 23.57)	2.37 (-4.72 , 5.32)
Mean (SD)	21.30 (5.17)	21.00 (4.75)	21.17 (4.84)
Median (IQR)	22.0 (17.0 – 26.0)	22.0 (17.0 – 24.5)	22.0 (17.0 – 26.0)
Difference FWB Subscore
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	-1.00 (-1.95 , -0.05)	-1.75 (-4.84 , 1.34)	-1.33 (-2.62 , -0.05)	0.75 (-1.90 , 3.40)
Mean (SD)	-1.00 (1.33)	-1.75 (3.69)	-1.33 (2.59)
Median (IQR)	-1.0 (-2.0 – 0.0)	-1.5 (-4.5 – 0.0)	-1.0 (-3.0 – 0.0)

22 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 3: Summary of Quality of Life Measures
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 6 of 6

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline PCS Subscore
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	33.90 (25.88 , 41.92)	37.11 (33.22 , 41.00)	35.42 (31.19 , 39.65)	3.21 (-11.80 , 5.38)
Mean (SD)	33.90 (11.21)	37.11 (5.06)	35.42 (8.77)
Median (IQR)	37.0 (27.0 – 43.0)	37.0 (34.0 – 40.0)	37.0 (31.0 – 43.0)
End of Study PCS Subscore
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	35.40 (30.12 , 40.68)	34.25 (30.74 , 37.76)	34.89 (31.89 , 37.89)	1.15 (-5.08 , 7.38)
Mean (SD)	35.40 (7.38)	34.25 (4.20)	34.89 (6.04)
Median (IQR)	35.0 (29.0 – 40.0)	33.0 (32.5 – 38.0)	33.0 (32.0 – 39.0)
Difference PCS Subscore
N (N Missing)	10 (0)	8 (1)	18 (1)
Mean (95% CL)	1.50 (-3.24 , 6.24)	-3.25 (-6.31 , -0.19)	-0.61 (-3.54 , 2.31)	4.75 (-0.80 , 10.30)
Mean (SD)	1.50 (6.62)	-3.25 (3.65)	-0.61 (5.88)
Median (IQR)	0.5 (-2.0 – 5.0)	-4.5 (-6.5 – 1.0)	-0.5 (-6.0 – 1.0)

23 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 4: Summary of Laboratory Values PART 1
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 1 of 4

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline Free Testosterone
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	42.31 (36.37 , 48.25)	78.53 (20.76 , 136.31)	59.47 (33.55 , 85.38)	-36.22 (-86.55 , 14.10)
Mean (SD)	42.31 (8.31)	78.53 (75.17)	59.47 (53.77)
Median (IQR)	42.4 (34.6 – 49.7)	57.4 (46.5 – 63.2)	46.5 (38.2 – 57.4)
End of Study Free Testosterone
N (N Missing)	8 (2)	7 (2)	15 (4)
Mean (95% CL)	42.09 (33.62 , 50.56)	42.94 (33.26 , 52.62)	42.49 (36.99 , 47.98)	-0.86 (-12.36 , 10.64)
Mean (SD)	42.09 (10.13)	42.94 (10.46)	42.49 (9.92)
Median (IQR)	43.6 (32.1 – 50.7)	43.1 (38.5 – 46.7)	43.1 (34.2 – 46.9)
Difference Free Testosterone
N (N Missing)	8 (2)	7 (2)	15 (4)
Mean (95% CL)	2.35 (-4.91 , 9.61)	-42.57 (-123.58 , 38.44)	-18.61 (-53.04 , 15.81)	44.92 (-21.99 , 111.84)
Mean (SD)	2.35 (8.69)	-42.57 (87.60)	-18.61 (62.16)
Median (IQR)	2.6 (-6.3 – 10.9)	-6.6 (-42.6 – -1.7)	-1.9 (-8.3 – 4.9)

24 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 4: Summary of Laboratory Values PART 1
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 2 of 4

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline Amylase
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	87.60 (52.14 , 123.06)	49.33 (32.42 , 66.25)	69.47 (48.86 , 90.09)	38.27 (0.37 , 76.16)
Mean (SD)	87.60 (49.56)	49.33 (22.01)	69.47 (42.76)
Median (IQR)	76.5 (50.0 – 100.0)	44.0 (30.0 – 63.0)	63.0 (44.0 – 84.0)
End of Study Amylase
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	82.11 (53.08 , 111.14)	58.63 (32.55 , 84.70)	71.06 (52.63 , 89.49)	23.48 (-12.61 , 59.58)
Mean (SD)	82.11 (37.76)	58.63 (31.19)	71.06 (35.84)
Median (IQR)	78.0 (55.0 – 105.0)	46.5 (40.0 – 73.5)	58.0 (46.0 – 87.0)
Difference Amylase
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	-7.33 (-21.11 , 6.44)	10.13 (-5.30 , 25.55)	0.88 (-9.27 , 11.04)	-17.45 (-36.27 , 1.36)
Mean (SD)	-7.33 (17.92)	10.13 (18.45)	0.88 (19.75)
Median (IQR)	-3.0 (-8.0 – 2.0)	1.5 (-1.0 – 16.0)	1.0 (-3.0 – 5.0)

25 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 4: Summary of Laboratory Values PART 1
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 3 of 4

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline CRP High Sensitivity
N (N Missing)	5 (5)	3 (6)	8 (11)
Mean (95% CL)	3.12 (-0.43 , 6.67)	3.50 (-8.99 , 15.99)	3.26 (0.37 , 6.15)	-0.38 (-7.04 , 6.28)
Mean (SD)	3.12 (2.86)	3.50 (5.03)	3.26 (3.45)
Median (IQR)	2.5 (0.6 – 5.2)	0.8 (0.4 – 9.3)	1.7 (0.5 – 6.1)
End of Study CRP High Sensitivity
N (N Missing)	5 (5)	3 (6)	8 (11)
Mean (95% CL)	2.46 (-0.20 , 5.12)	1.57 (-2.62 , 5.76)	2.13 (0.53 , 3.72)	0.89 (-2.68 , 4.47)
Mean (SD)	2.46 (2.14)	1.57 (1.69)	2.13 (1.91)
Median (IQR)	1.6 (0.8 – 4.0)	0.8 (0.4 – 3.5)	1.2 (0.7 – 3.8)
Difference CRP High Sensitivity
N (N Missing)	5 (5)	3 (6)	8 (11)
Mean (95% CL)	-0.66 (-2.30 , 0.98)	-1.93 (-10.25 , 6.39)	-1.14 (-2.94 , 0.66)	1.27(-2.68 , 5.23)
Mean (SD)	-0.66 (1.32)	-1.93 (3.35)	-1.14 (2.15)
Median (IQR)	-1.2 (-1.5 – 0.2)	0.0 (-5.8 – 0.0)	-0.6 (-1.8 – 0.1)

26 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 4: Summary of Laboratory Values PART 1
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 4 of 4

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline C Reactive Protein
N (N Missing)	5 (5)	6 (3)	11 (8)
Mean (95% CL)	0.50 (0.15 , 0.84)	0.56 (0.10 , 1.02)	0.53 (0.29 , 0.77)	-0.06 (-0.58 , 0.45)
Mean (SD)	0.50 (0.28)	0.56 (0.44)	0.53 (0.36)
Median (IQR)	0.5 (0.3 – 0.6)	0.3 (0.3 – 0.9)	0.4 (0.3 – 0.9)
End of Study C Reactive Protein
N (N Missing)	4 (6)	5 (4)	9 (10)
Mean (95% CL)	0.67 (0.10 , 1.24)	0.37 (0.04 , 0.70)	0.50 (0.25 , 0.76)	0.30 (-0.18 , 0.79)
Mean (SD)	0.67 (0.36)	0.37 (0.26)	0.50 (0.33)
Median (IQR)	0.7 (0.4 – 0.9)	0.3 (0.3 – 0.3)	0.3 (0.3 – 0.8)
Difference C Reactive Protein
N (N Missing)	4 (6)	5 (4)	9 (10)
Mean (95% CL)	0.12 (-0.49 , 0.72)	-0.22 (-0.80 , 0.36)	-0.07 (-0.41 , 0.27)	0.33 (-0.35 , 1.02)
Mean (SD)	0.12 (0.38)	-0.22 (0.47)	-0.07 (0.44)
Median (IQR)	0.2 (-0.2 – 0.4)	0.0 (-0.0 – 0.0)	0.0 (-0.0 – 0.0)

27 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 5: Summary of Laboratory Values PART 2
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 1 of 8

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline HDL
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	57.50 (47.44 , 67.56)	53.33 (46.12 , 60.54)	55.53 (49.77 , 61.28)	4.17 (-7.55 , 15.89)
Mean (SD)	57.50 (14.07)	53.33 (9.38)	55.53 (11.94)
Median (IQR)	52.0 (46.0 – 74.0)	53.0 (44.0 – 58.0)	53.0 (46.0 – 67.0)
End of Study HDL
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	57.22 (46.33 , 68.11)	56.00 (47.38 , 64.62)	56.65 (50.41 , 62.89)	1.22 (-11.74 , 14.18)
Mean (SD)	57.22 (14.17)	56.00 (10.31)	56.65 (12.13)
Median (IQR)	58.0 (45.0 – 63.0)	57.0 (48.0 – 64.5)	58.0 (46.0 – 63.0)
Difference HDL
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	-2.33 (-6.68 , 2.01)	2.25 (-2.78 , 7.28)	-0.18 (-3.32 , 2.97)	-4.58 (-10.62 , 1.45)
Mean (SD)	-2.33 (5.66)	2.25 (6.02)	-0.18 (6.12)
Median (IQR)	-1.0 (-7.0 – 2.0)	2.5 (-4.0 – 7.0)	0.0 (-4.0 – 5.0)

28 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 5: Summary of Laboratory Values PART 2
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 2 of 8

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline LDL Cholesterol Direct
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	120.10 (98.61 , 141.59)	110.44 (87.64 , 133.25)	115.53 (101.33 , 129.72)	9.65 (-19.30 , 38.61)
Mean (SD)	120.10 (30.04)	110.44 (29.67)	115.53 (29.45)
Median (IQR)	114.5 (101.0 – 129.0)	111.0 (85.0 – 135.0)	113.0 (88.0 – 135.0)
End of Study LDL Cholesterol Direct
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	118.22 (95.39 , 141.06)	109.13 (75.43 , 142.82)	113.94 (96.32 , 131.56)	9.09 (-27.21 , 45.40)
Mean (SD)	118.22 (29.71)	109.13 (40.31)	113.94 (34.26)
Median (IQR)	112.0 (105.0 – 129.0)	98.5 (78.5 – 126.0)	108.0 (85.0 – 129.0)
Difference LDL Cholesterol Direct
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	-0.89 (-11.15 , 9.38)	4.00 (-16.35 , 24.35)	1.41 (-8.27 , 11.10)	-4.89 (-24.86 , 15.08)
Mean (SD)	-0.89 (13.36)	4.00 (24.34)	1.41 (18.84)
Median (IQR)	2.0 (-8.0 – 7.0)	1.5 (-8.5 – 9.0)	2.0 (-8.0 – 7.0)

29 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 5: Summary of Laboratory Values PART 2
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 3 of 8

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline Lipase
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	110.40 (53.52 , 167.28)	90.56 (8.47 , 172.64)	101.00 (57.00 , 145.00)	19.84 (-70.64 , 110.33)
Mean (SD)	110.40 (79.51)	90.56 (106.78)	101.00 (91.28)
Median (IQR)	118.5 (31.0 – 170.0)	58.0 (43.0 – 85.0)	67.0 (31.0 – 153.0)
End of Study Lipase
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	100.44 (34.78 , 166.10)	152.38 (45.21 , 259.54)	124.88 (69.62 , 180.14)	-51.93 (-163.28 , 59.42)
Mean (SD)	100.44 (85.42)	152.38 (128.18)	124.88 (107.47)
Median (IQR)	95.0 (36.0 – 119.0)	113.5 (60.0 – 213.5)	101.0 (36.0 – 180.0)
Difference Lipase
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	5.22 (-34.89 , 45.34)	57.75 (-1.74 , 117.24)	29.94 (-3.80 , 63.69)	-52.53 (-116.50 , 11.45)
Mean (SD)	5.22 (52.19)	57.75 (71.16)	29.94 (65.63)
Median (IQR)	-3.0 (-7.0 – 6.0)	35.5 (5.0 – 90.5)	6.0 (-3.0 – 37.0)

30 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 5: Summary of Laboratory Values PART 2
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 4 of 8

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline Sedimentation Rate ESR
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	11.50 (7.15 , 15.85)	11.67 (4.89 , 18.44)	11.58 (8.07 , 15.09)	-0.17 (-7.43 , 7.10)
Mean (SD)	11.50 (6.08)	11.67 (8.82)	11.58 (7.28)
Median (IQR)	10.0 (8.0 – 13.0)	10.0 (6.0 – 16.0)	10.0 (6.0 – 16.0)
End of Study Sedimentation Rate ESR
N (N Missing)	8 (2)	8 (1)	16 (3)
Mean (95% CL)	8.50 (6.09 , 10.91)	9.75 (6.27 , 13.23)	9.13 (7.25 , 11.00)	-1.25 (-5.09 , 2.59)
Mean (SD)	8.50 (2.88)	9.75 (4.17)	9.13 (3.52)
Median (IQR)	7.5 (6.5 – 11.0)	10.0 (6.5 – 12.5)	9.5 (6.5 – 12.0)
Difference Sedimentation Rate ESR
N (N Missing)	8 (2)	8 (1)	16 (3)
Mean (95% CL)	-2.00 (-5.52 , 1.52)	-1.38 (-6.70 , 3.95)	-1.69 (-4.47 , 1.10)	-0.63 (-6.41 , 5.16)
Mean (SD)	-2.00 (4.21)	-1.38 (6.37)	-1.69 (5.22)
Median (IQR)	-1.5 (-2.5 – -0.5)	0.0 (-3.0 – 2.5)	-0.5 (-2.5 – 1.0)

31 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 5: Summary of Laboratory Values PART 2
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 5 of 8

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline TSH
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	1.52 (0.86 , 2.18)	2.01 (1.24 , 2.79)	1.75 (1.29 , 2.22)	-0.49 (-1.42 , 0.44)
Mean (SD)	1.52 (0.92)	2.01 (1.01)	1.75 (0.97)
Median (IQR)	1.2 (1.1 – 1.9)	1.6 (1.2 – 2.7)	1.5 (1.2 – 2.1)
End of Study TSH
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	1.87 (1.08 , 2.65)	2.21 (1.50 , 2.92)	2.03 (1.55 , 2.51)	-0.35 (-1.32 , 0.63)
Mean (SD)	1.87 (1.02)	2.21 (0.85)	2.03 (0.93)
Median (IQR)	1.6 (0.9 – 2.6)	2.0 (1.4 – 3.0)	1.9 (1.4 – 2.6)
Difference TSH
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	0.26 (-0.04 , 0.55)	0.09 (-0.21 , 0.39)	0.18 (-0.01 , 0.37)	0.17 (-0.21 , 0.55)
Mean (SD)	0.26 (0.38)	0.09 (0.36)	0.18 (0.37)
Median (IQR)	0.3 (0.0 – 0.5)	0.1 (-0.2 – 0.3)	0.2 (-0.1 – 0.4)

32 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 5: Summary of Laboratory Values PART 2
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 6 of 8

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline Testosterone Bioavailable
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	85.81 (75.31 , 96.31)	106.57 (84.77 , 128.36)	95.64 (84.05 , 107.23)	-20.75 (-42.27 , 0.75)
Mean (SD)	85.81 (14.67)	106.57 (28.36)	95.64 (24.05)
Median (IQR)	81.4 (75.6 – 102.1)	100.3 (80.4 – 118.8)	87.6 (75.7 – 109.0)
End of Study Testosterone Bioavailable
N (N Missing)	8 (2)	7 (2)	15 (4)
Mean (95% CL)	85.14 (66.93 , 103.34)	89.04 (68.39 , 109.69)	86.96 (75.15 , 98.77)	-3.91 (-28.54 , 20.73)
Mean (SD)	85.14 (21.78)	89.04 (22.33)	86.96 (21.33)
Median (IQR)	88.1 (63.7 – 101.6)	86.8 (77.4 – 93.3)	87.9 (65.9 – 95.0)
Difference Testosterone Bioavailable
N (N Missing)	8 (2)	7 (2)	15 (4)
Mean (95% CL)	3.69 (-9.08 , 16.45)	-16.76 (-49.41 , 15.89)	-5.85 (-21.14 , 9.44)	20.44 (-9.16 , 50.04)
Mean (SD)	3.69 (15.27)	-16.76 (35.30)	-5.85 (27.61)
Median (IQR)	4.6 (-12.0 – 19.3)	-8.2 (-22.3 – 4.7)	-1.7 (-14.7 – 16.6)

33 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 5: Summary of Laboratory Values PART 2
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 7 of 8

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline Testosterone Total
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	432.30 (358.76 , 505.84)	441.67 (320.58 , 562.76)	436.74 (375.13 , 498.34)	-9.37 (-136.77 , 118.04)
Mean (SD)	432.30 (102.81)	441.67 (157.53)	436.74 (127.82)
Median (IQR)	443.0 (372.0 – 503.0)	433.0 (313.0 – 607.0)	433.0 (325.0 – 554.0)
End of Study Testosterone Total
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	536.44 (334.24 , 738.65)	388.63 (259.90 , 517.35)	466.88 (351.05 , 582.72)	147.82 (-79.01 , 374.66)
Mean (SD)	536.44 (263.06)	388.63 (153.97)	466.88 (225.29)
Median (IQR)	489.0 (390.0 – 593.0)	360.5 (288.5 – 493.0)	394.0 (339.0 – 587.0)
Difference Testosterone Total
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	109.89 (-47.36 , 267.13)	-52.75 (-172.53 , 67.03)	33.35 (-65.42 , 132.13)	162.64 (-22.33 , 347.61)
Mean (SD)	109.89 (204.57)	-52.75 (143.27)	33.35 (192.11)
Median (IQR)	69.0 (13.0 – 107.0)	3.5 (-102.5 – 41.5)	22.0 (-64.0 – 69.0)

34 of 35
Protocol ID: 2000020868
PI: Michael S. Leapman, MD
Title: Nutrition and Prostate Cancer
Funded by: BESO Biological Research Center, Inc.
Table 5: Summary of Laboratory Values PART 2
Source Data: Nutrition and Prostate Cancer dataset, locked on: 07/09/2020. Tables generated using SAS Version 9.4: Proc Report.
Report Creation Date: 24SEP20
page 8 of 8

Characteristic	Daily QC (n=10)	Placebo (n=9)	Total (n=19)	Difference (95% CI)
Baseline Triglycerides
N (N Missing)	10 (0)	9 (0)	19 (0)
Mean (95% CL)	104.70 (56.12 , 153.28)	95.78 (64.88 , 126.68)	100.47 (73.88 , 127.07)	8.92 (-45.93 , 62.78)
Mean (SD)	104.70 (67.91)	95.78 (40.20)	100.47 (55.18)
Median (IQR)	89.5 (54.0 – 133.0)	79.0 (72.0 – 127.0)	79.0 (56.0 – 133.0)
End of Study Triglycerides
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	103.00 (69.12 , 136.88)	103.25 (55.16 , 151.34)	103.12 (77.83 , 128.40)	-0.25 (-52.85 , 52.36)
Mean (SD)	103.00 (44.08)	103.25 (57.52)	103.12 (49.18)
Median (IQR)	101.0 (66.0 – 116.0)	77.0 (58.0 – 155.5)	86.0 (66.0 – 145.0)
Difference Triglycerides
N (N Missing)	9 (1)	8 (1)	17 (2)
Mean (95% CL)	17.11 (-3.64 , 37.86)	1.00 (-31.22 , 33.22)	9.53 (-7.39 , 26.45)	16.11 (-17.96 , 50.18)
Mean (SD)	17.11 (26.99)	1.00 (38.54)	9.53 (32.91)
Median (IQR)	19.0 (0.0 – 34.0)	-1.5 (-23.0 – 5.5)	4.0 (-4.0 – 22.0)

35 of 35

Efficacy and toxicity studies on unique branched chain fatty acids and their derivatives as potential anticancer agents

Prostate-Specifc Antigen Modulatory Eﬀect of a Fermented Soy Supplement for Patients with an Elevated Risk of Prostate Cancer

Efficacy and toxicity studies on unique branched chain fatty acids and their derivatives as potential anticancer agents

Prostate-Specifc Antigen Modulatory Eﬀect of a Fermented Soy Supplement for Patients with an Elevated Risk of Prostate Cancer

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