PRostate Cancer Individual Signature Evaluation Trial in Patients Undergoing Scheduled Prostate Biopsy

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00966095

Acronym

PReCISE

Enrollment

1200

Registered

2009-08-26

Start date

2009-12-31

Completion date

Unknown

Last updated

2010-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results