Clinical trial · Observational
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
NCT00966095CI-TRIAL-00004131PReCISEunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- men scheduled for prostate biopsy
Primary outcomes (1)
- measure
- ability of whole blood gene expression to predict biopsy outcome
- timeFrame
- pre-biopsy
Secondary outcomes (1)
- measure
- Prediction of tumor aggressiveness using whole blood gene expression
- timeFrame
- post-biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.