25 148
3. Intermediate risk: PSA 10
–
15 ng/ml or Gleason score 7, who should be
classified as having CS cancer
4. High risk: Gleason score 8, who should be classified as having CS
cancer
2.4.
Management post diagnosis
The long-term outcomes of men with cancer were based on the Prostate
Cancer Intervention Versus Observation Trial (PIVOT)
[8] ,a randomised
controlled trial comparing radical prostatectomy and watchful waiting
in men with localised prostate cancer, by risk subgroup as de
fi
ned
above. The information from PIVOT was combined with that from the
STAMPEDE study (metastatic subgroup)
[9]in a calibration model in
order to estimate the probability of transition between the Markov
model health states. Since the diagnostic strategies are perfectly speci
fi
c,
only men with intermediate- or high-risk cancer are classi
fi
ed as having
CS cancer and receive treatment. Details are provided in the Supple-
mentary material, section 3.
2.5.
Health-related quality of life and costs
For health-related quality of life (HRQoL), the model considers the direct
impact of TPMB, obtained from the patient-reported EQ-5D collected in
the PROMIS
[4] .TRUSB is assumed to have no impact on HRQoL given
that no effect was found in a large European screening study
[10]. Regarding costs, the model included the direct cost of the tests
and the costs associated with managing their related complications
[11,12].
In the long term, the model considers the reduction in HRQoL from
any metastatic disease
[13]and ageing
[14] .The model included the
direct cost of radical prostatectomy and surveillance, the costs of their
complications, and the costs of metastatic disease
[8]. Details are
Table 3
–
Diagnostic performance of MPMRI
Subgroups
No cancer
Low-risk cancer
Intermediate-risk cancer
High-risk cancer
Cut-off
De
fi
nition NC non-CS
CS
NC non-CS
CS
NC non-CS
CS
NC non-CS
CS
2
1
0.00
0.23
0.77 0.00
0.20
0.80 0.01
0.06
0.93 0.00
0.00
1.00
2
0.00
0.07
0.93 0.00
0.08
0.92 0.01
0.01
0.98 0.00
0.00
1.00
3
1
0.33
0.41
0.26 0.28
0.40
0.32 0.08
0.18
0.74 0.00
0.00
1.00
2
0.33
0.17
0.50 0.28
0.16
0.56 0.08
0.05
0.87 0.00
0.00
1.00
4
1
0.86
0.08
0.06 0.75
0.14
0.11 0.30
0.24
0.46 0.00
0.06
0.94
2
0.86
0.03
0.11 0.75
0.04
0.21 0.30
0.04
0.65 0.00
0.00
1.00
=5
1
0.96
0.02
0.02 0.98
0.01
0.01 0.60
0.17
0.23 0.23
0.16
0.61
2
0.96
0.01
0.03 0.98
0.00
0.02 0.60
0.03
0.38 0.23
0.00
0.77
CS = clinically signi
fi
cant; MPMRI = multiparametric magnetic resonance imaging; NC = no cancer; PROMIS = Prostate MR Imaging Study.
Parameter inputs are presented as point estimates (mean). See the Supplementary material, section 2, for 95% con
fi
dence intervals.
The diagnostic performance of MPMRI was obtained from the individual patient data of the PROMIS
[4] .For interpretation of MPMRI, the de
fi
nitions for CS
cancer were a radiologist estimation of (1) lesion volume 0.5 cc and/or Gleason score 4 + 3, and (2) lesion volume 0.2 cc and/or Gleason score 3
+ 4. Suspicion of a lesion meeting these de
fi
nitions was scored on a Likert scale (1
–
5, 1 being highly likely benign and 5 being highly likely malignant). This scale
was also used to score the image for whether any cancer (whether considered CS or not) is present.
Table 2
–
Diagnostic performance of TRUSB
Subgroups
Low-risk cancer
Intermediate-risk cancer
High-risk cancer
Source
Type
De
fi
nition
NC non-CS
CS
NC non-CS
CS
NC non-CS
CS
1
1
0.65
0.35
0.00
0.24
0.42
0.34
0.00
0.00
1.00
PROMIS
[4]2
0.65
0.35
0.00
0.24
0.17
0.59
0.00
0.00
1.00
2
1
0.55
0.45
0.00
0.55
0.25
0.20
0.55
0.00
0.45
[22]2
0.55
0.45
0.00
0.55
0.10
0.35
0.55
0.00
0.45
3
1
0.00
1.00
0.00
0.00
0.75
0.25
0.00
0.75
0.25
[23]2
0.00
1.00
0.00
0.00
0.75
0.25
0.00
0.75
0.25
4
1
0.80
0.20
0.00
0.20
0.37
0.43
0.00
0.00
1.00
PROMIS
[4]combined with
[16]2
0.79
0.21
0.00
0.15
0.11
0.74
0.00
0.00
1.00
5
1 and 2
0.68
0.32
0.00
0.05
0.08
0.87
0.05
0.08
0.87
[16]CS = clinically signi
fi
cant; MPMRI = multiparametric magnetic resonance imaging; NC = no cancer; PROMIS = Prostate MR Imaging Study; TPMB = template
prostate mapping biopsy; TRUSB = transrectal ultrasound-guided biopsy.
Key:
1: TRUSB before MPMRI
2: TRUSB after a TRUSB that did not detect cancer
3: TRUSB after a TRUSB that detected CNS cancer
4: TRUSB after a suspicious MPMRI
5: TRUSB after a TRUSB that did not detect cancer and a suspicious MPMRI
Parameter inputs are presented as point estimates (mean). See the Supplementary material, section 2, for 95% con
fi
dence intervals and details on the data
sources.
The diagnostic performance of the
fi
rst TRUSB (i.e. TRUSB type 1) was obtained from the individual patient data of the PROMIS
[4]. For TRUSB and TPMB, the
histological CS cancer de
fi
nitions were (1) dominant Gleason pattern 4 and/or any Gleason pattern 5 and/or cancer core length 6 mm (histology de
fi
nition
1) and (2) any Gleason pattern 4 and/or cancer core length 4 mm (histology de
fi
nition 2). Since the PROMIS collected information on blind
fi
rst TRUSB,
external evidence was used on the sensitivity of repeat TRUSB and MRI-targeted TRUSB, as either
fi
rst or second TRUSB
[16,22,23].
E U R O P E A N U R O L O GY 7 3 ( 2 0 18 ) 2 3
–
3 0
25