Overview

This trial is active, not recruiting.

Condition prostate cancer
Sponsor Source MDx
Start date December 2009
Trial size 1200 participants
Trial identifier NCT00966095, PReCISE

Summary

The purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will serve to reduce the number of unnecessary prostate biopsies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm

Primary Outcomes

Measure
ability of whole blood gene expression to predict biopsy outcome
time frame: pre-biopsy

Secondary Outcomes

Measure
Prediction of tumor aggressiveness using whole blood gene expression
time frame: post-biopsy

Eligibility Criteria

Male participants at least 40 years old.

Inclusion Criteria:. 1. Male over the age of 40. 2. Patient is scheduled for prostate biopsy for one or more of the following reasons: - PSA > 2.5 ng/ml - Rising PSA (>0.5 ng/ml/yr) - Lower PSA value with other risk factors for prostate cancer (e.g.; family history) - Abnormal DRE - Percent free PSA <15% 3. No prior history of prostate cancer or prostate biopsy. Exclusion Criteria: - Unable or unwilling to provide informed consent

Additional Information

Official title A Prospective, Multi-Center PRostate Cancer Individual Signature Evaluation Trial (PReCISE) in Patients Undergoing Scheduled Prostate Biopsy
Principal investigator William Oh, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by Source MDx.