The early detection research network surface-enhanced laser desorption and ionization prostate cancer detection study: A study in biomarker validation in genitourinary oncology.
Prostate-specific antigen (PSA) screening has led to a dramatic increase in prostate cancer detection with a concurrent stage migration. Although the test has revolutionized prostate cancer detection by identifying disease that is potentially curable in the majority of men, only 25% of men receiving test results of PSA > 4 ng/ml will have prostate cancer and many men receiving a normal PSA will have disease, including high-grade disease. There is a need for improved biomarkers for detecting prostate cancer. One such method of cancer detection is surface-enhanced laser desorption and ionization (SELDI). The Early Detection Research Network (EDRN) validation study for SELDI for prostate cancer is described. In a three-stage study, the portability and reproducibility of the technique will be determined; the predictive algorithm will be refined in a multi-institutional case-control population; followed by ultimate validation in the context of a prospective trial with complete disease ascertainment. The unique aspect of the EDRN SELDI validation study is the novel use of two groups of cancer cases: those cases with higher-risk disease (Gleason > or = 7) and those cases with lower-risk disease (Gleason < or = 6). This study will allow the first evaluation of a predictive algorithm that includes prognosis in disease screening. The EDRN SELDI prostate cancer biomarker validation study is a rigorous evaluation of a new detection method for prostate cancer. The methodologies used for this evaluation will prove useful for guiding future biomarker studies in this challenging disease.
Grizzle
William E
WE
University of Alabama at Birmingham, Birmingham, AL, USA.
Semmes
O John
OJ
Basler
Joseph
J
Izbicka
Elzbieta
E
Feng
Ziding
Z
Kagan
Jacob
J
Adam
Bao-Ling
BL
Troyer
Dean
D
Srivastava
Sudhir
S
Thornquist
Mark
M
Zhang
Zhen
Z
Thompson
Ian M
IM
D014408:Biomarkers, Tumor / Q000032:analysis*; D001706:Biopsy; D006801:Humans; D007834:Lasers; D008297:Male; D008403:Mass Screening; D013058:Mass Spectrometry / Q000379:methods; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000473:pathology; D040081:Protein Array Analysis / Q000379:methods*; D012680:Sensitivity and Specificity
D014408:Biomarkers, Tumor