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Clinical Trials/NCT00966095
NCT00966095
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A Prospective, Multi-Center PRostate Cancer Individual Signature Evaluation Trial (PReCISE) in Patients Undergoing Scheduled Prostate Biopsy

Source MDx17 sites in 1 country1,200 target enrollmentDecember 2009
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ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Source MDx
Enrollment
1200
Locations
17
Primary Endpoint
ability of whole blood gene expression to predict biopsy outcome
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
TBD
Last Updated
15 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Source MDx

Eligibility Criteria

Inclusion Criteria

  • •Male over the age of
  • •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%
  • •No prior history of prostate cancer or prostate biopsy.

Exclusion Criteria

  • •Unable or unwilling to provide informed consent

Outcomes

Primary Outcomes

ability of whole blood gene expression to predict biopsy outcome

Time Frame: pre-biopsy

Secondary Outcomes

  • Prediction of tumor aggressiveness using whole blood gene expression(post-biopsy)

Study Sites (17)

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