Abbreviated Name

Prostate Rapid Ref Set App: Chan/Beckman (2007)

Lead Investigator

Chan, Daniel — Johns Hopkins Medical Institutions

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Chan, Daniel — Johns Hopkins Medical Institutions
• Srivastava, Sudhir — National Cancer Institute
• Zheng, Yingye — Fred Hutchinson Cancer Center

Abstract

Evaluate performance of [-2]proPSA as an early detection marker for prostate cancer

Aims

Evaluate performance of [-2]proPSA as an early detection marker for prostate cancer

Analytic Method

Specimens were analyzed in a blinded fashion at Beckman Coulter, Inc. on the Beckman Coulter ACCESS 2 immunoassay system for PSA, free PSA, [-2]proPSA, BPSA and testosterone. The PSA assays are all dual monoclonoal sandwich assays using Hybritech antibodies and chemiluminescent detection system. The assays for PSA, free PSA and testosterone are commercially available which the assays for [-2]proPSA and BPSA are for research use only.

Comments

No comments available.

Outcome

There was no difference in total PSA concentrations (non-cancer: 6.80+/-5.20 ng/mL, cancer: 6.94=/-5.12 ng/mL) between the groups. Overall %[-2]proPSA had the greatest area under the curve (AUC=0.69) followed by %fPSA (AUC=0.61). For %[-2]proPSA, maximal sensitivity was 60% and specificity was 70%. A logistic regression model combining PSA, BPSA, %fPSA, %[-2]proPSA, %[-2]proPSA/BPSA, and tesosterone had an AUC of 0.73. In the 2-10ng/mL PSA range %[-2]proPSA and the model had the largest AUC (0.73). The AUC for %fPSA was 0.53. Specificities for %[-2]proPSA, the logistic regression model and %fPSA at 90% sensitivity were 41%, 32% and 18% and at 95% sensitivity were 31%, 26% and 16% respectively.

Secure Outcome

No secure outcome available.

Publications

• [-2]proenzyme prostate specific antigen for prostate cancer detection: a national cancer institute early detection research network validation study.

Biomarkers

• BPSA
• fPSA
• proPSA
• PSA
• Testosterone

Data Collections

• No data collections available at this time for this protocol.

 Team Project

Start Date

Feb 1 2006

Estimated Finish Date

Feb 1 2007

Finish Date

Sep 15 2006

Protocol ID

284

Protocol Type

Reference Set

Fields of Research

• Proteomics

Collaborative Group

Prostate and Urologic Cancers Research Group

Cancer Types

• Malignant neoplasm of prostate

Phased Status

1