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

Source MDx

Status: Unknown

Conditions: Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT00966095

PReCISE

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,200 participants in 1 patient group

men scheduled for prostate biopsy