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.
University of Alabama at Birmingham, Birmingham, AL, USA.
William E
WE
Grizzle
O John
OJ
Semmes
Joseph
J
Basler
Elzbieta
E
Izbicka
Ziding
Z
Feng
Jacob
J
Kagan
Bao-Ling
BL
Adam
Dean
D
Troyer
Sudhir
S
Srivastava
Mark
M
Thornquist
Zhen
Z
Zhang
Ian M
IM
Thompson
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