Table 2Reported criteria for specific inclusion/exclusion of subjects for studies

Table 2aReported criteria for specific inclusion/exclusion of subjects for studies addressing KQ 1 and KQ 2

Authora,b, YeartPSA Cutoff (ng/ml)Abnormal DRE (%)Positive BiopsyInitial Biopsy (%)Positive Family History (%)African-AmericanOther Risk FactorsSpecific Exclusion Criteria
Adam90, 2011All valuesYesNo82YesYesNRBPH, indwelling catheters
Ankerst65, 2008≥2.5Yes (19)No05.9NRNRNR
Aubin91, 20102.5-10 (<60y) 3-10 (≥60y)NoNo0NoNRNRtPSA levels >10; meds that affect tPSA levels; HGPIN, ASAP
Auprich92, 2011≥2.5 to 6.5 - 50Yes (11)No0NRNRNRtPSA levels > 50
Bollito93, 2012≥ 2.5NoNo59NRNRNRSuspicious DRE; HGPIN; ASAP
Cao94, 2011≥4YesNoNRNRNRNRMeds that affect tPSA levels
de la Taille95, 20112.5-10Yes (19)No100NRNRNRtPSA levels >10
Deras96, 2008≥ 2.5Yes (15)No50YesYesYesNR
FDA Summary97, 2012NRYesNo0NRYesNRMeds that affect tPSA levels; UTI / prostatitis; treatment
Feero98, 20122.0-20NoNo100NRNRNRtPSA levels > 20
Goode99, 2012≥ 4YesNo63NRNRNRNR
Hessels100, 2010>3YesNoMixed; NRYesNRNRNR
Mearini101, 2009>1YesNoNRNRNRNRNR
Nyberg102, 2010≥ 2.5YesNo55NRNRNRNR
Ochiai103, 20112.5-50YesNo81NRNRNRMeds that affect tPSA levels
Ouyang104, 2009≥ 4NRNoNRNRNRNRNR
Pepe105, 20124-10YesNo0NRNRNRtPSA levels > 10
Perdona31, 2011< 10Yes (22)No61NoNoNRtPSA levels > 10; meds that affect tPSA levels; previous dx PCa
Ploussard1062.5-10NoNo0NRNRNRtPSA levels > 10; , meds that affect tPSA levels; initial biopsies
Rigau107, 2010≥ 4Yes (26)No74NRNRNRMeds that affect tPSA levels
Roobol108, 2010≥ 3.0NoNo71NoNRNRNR
Schilling109, 2010>4YesNo56NoNoNRNR
Wang110, 2009NRYesNo73Yes (19)NRYesHistory PCa
Wu111, 2012≥ 10Yes (13)No0NRNRNRNR

Table 2bReported criteria for specific inclusion/exclusion of subjects for studies addressing KQ 3

Authora,b, YearPositive BiopsyDescriptionSpecific Exclusion Criteria
Auprich112, 2011YesClinically localized PrCMeds that affect PSA levels
Durand113, 2012YesLocalized PrCNR
Hessels100, 2010YesPrCNR
Kusuda88, 2011YesClinically localized PrCNR
Liss114, 2011YesPrCNR
Nakanishi115, 2008YesPrCNot age 40-70, PSA levels ≥ 50; or taking meds that affect PSA levels
Ploussard116, 2011Yes“Low risk” localized PrCNot “low risk” (PSA ≤ 10; stage T1c-T2a; Gleason score 6)
Tosoian89, 2010Yes“Low risk” PrC patients (Epstein criteria) in a surveillance programPositive biopsy but not “low risk” based on Epstein criteria
van Poppel117, 2011YesBiopsy positive PrCNR
Vlaeminck-Guillem118, 2011YesBiopsy positiveNeoadjuvant treatment
Whitman119, 2008YesBiopsy positiveMeds that affect PSA levels

ASAP = atypical small acinar proliferation; BPH = benign prostatic hyperplasia; DRE = digital rectal exam; HGPIN = high-grade prostatic intraepithelial neoplasia; NA = Not applicable; No = Not a criterion for inclusion; NR = not reported; PrC = prostate cancer; PSA = prostate specific antigen; tPSA = total prostate specific antigen; UTI = urinary tract infection

a

In alphabetical order for KQ 1/KQ 2 studies (N=24) in Table 2a, then in alphabetical order for KQ 3 studies (N=11) in Table 2b.

b

Shaded rows indicate studies focusing on the “grey zone” of tPSA (e.g., 2.5-10 ng/mL) when enrolling patients. In Table 2a, rows 3, 7, 10, and 17-19 are shaded. There is no shading in Table 2b.

From: Results

Cover of PCA3 Testing for the Diagnosis and Management of Prostate Cancer
PCA3 Testing for the Diagnosis and Management of Prostate Cancer [Internet].
Comparative Effectiveness Reviews, No. 98.
Bradley LA, Palomaki G, Gutman S, et al.

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