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
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
 

B. Enrollment, Randomization and Baseline
1. Enrollment plot
8 9