Table 1. Patient Characteristics, All Subjects (N=490)
Age
< 65 years old
≥ 65 years old
Range
Race/ethnicity
African American
White
Other
Not reported
Comorbidities (CCI Score)
0
1-2
>2
Screening eligibility
PSA test (≥ 4.0 ng/mL)
Abnormal PSA velocity
Digital rectal exam (DRE)
Baseline PSA
< 4 ng/mLa
4 ng/mL - 10 ng/mL
> 10 ng/mL
Missing (Eligible by DRE)
Cancer diagnosis
No cancer/resolved with PSA
Cancer
Unresolved
Navigated
(N=245)
N (%)
Control
(N=245)
N (%)
142 (58)
103 (42)
48-79
119 (49)
126 (51)
42-92
155 (63)
68 (28)
20 (8)
2 (1)
177 (72)
37 (15)
7 (3)
24 (10)
p-value
0.046
<0.0001
0.72
96 (39)
114 (47)
35 (14)
90 (37)
123 (50)
32 (13)
0.058
204 (83)
26 (11)
15 (6)
210 (86)
13 (5)
22 (9)
26 (11)
164 (71)
40 (17)
15 (6)
11 (5)
154 (69)
58 (26)
22 (9)
0.011
0.54
127 (52)
84 (34)
34 (14)
117 (48)
86 (35)
42 (17)
Abbreviations: sd, standard deviation; CCI, Charlson Comorbidity Index; PSA, prostate specific
antigen; ng/mL, nanogram per milliliter; DRE, digital rectal exam
a
Values may not sum to all subjects who enrolled on abnormal PSA velocity due to rounded PSA
value
Table 2. Patient Characteristics, Subjects with Cancer (N=170)
Age
< 65 years old
≥ 65 years old
Range
Race/ethnicity
African American
White
Other
Not reported
Gleason score
≤ 3+3
> 3+3
Consultation beyond Urologya
Yes
No
Primary Therapy
Prostatectomy
External Radiation Therapy
Hormone Therapy
Watchful Waiting
Interstitial Radiation Therapy
Cryotherapy
Treatment not initiated
Navigated
(N=84)
N (%)
Control
(N=86)
N (%)
47 (56)
37 (44)
50-79
39 (45)
47 (55)
43-92
53 (63)
23 (27)
7 (8)
1 (1)
64 (74)
13 (15)
2 (2)
7 (8)
p-value
0.17
0.011
0.008
45 (54)
39 (46)
28 (33)
58 (67)
35 (42)
49 (58)
42 (49)
44 (51)
0.36
0.45
26 (30)
14 (17)
17 (20)
15 (18)
2 (2)
1 (1)
9 (11)
24 (28)
13 (15)
28 (33)
14 (28)
0 (0)
0 (0)
7 (8)
Abbreviations: sd, standard deviation
a
Consultation with radiation oncologist, medical oncologist, or surgeon
Table 3. Summary of analyses of time to diagnostic resolution (Time 1) and time to
treatment initiation (Time 2)
Analysis
Category
Study
Arm
Sample
Size
Event
Time 1: Time from abnormal screening to diagnostic resolution
Time 1
0-80 days
Navigated
245
95 (38.8%)
stratified by
Control
245
96 (39.2%)
diagnostic
81-365
days
resolution
Navigated
146
116 (79.4%)
time
interval
Control
148
107 (72.3%)
Time 2: Time from diagnostic resolution to treatment initiation
Time 2
0-365 days
Navigated
84
75 (89.3%)
overall
Control
86
79 (91.9%)
Median
Days
Log
rank
pvalue
Adj.
H.R.a
Adj.
95% C.I.
Adj.
pvalue
0.45
0.91
0.67 – 1.23
0.53
0.015
1.41
1.07 - 1.86
0.01
0.36
1.15
0.82 - 1.62
0.41
68b
55b
151
190
93
87
Abbreviations: ERT, external radiation therapy; IRT, interstitial radiation therapy; N/A, no
statistics calculated
For Time 1, age (< 65, ≥ 65) and race (African American vs. non-African American) were used as
covariates. For Time 2, age (< 65, ≥ 65), race (African American, non-African American), and Gleason
score (≤ 6, > 6) were used as covariates.
a
b
25th percentile since median not attained