Clinical trial · Observational
Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer
Paired CAP: Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer
NCT02425228CI-TRIAL-00046147Paired CapcompletedClinicalTrials.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)
This is a pilot study to determine cancer detection rate of conventional/systematic versus targeted biopsy methods in diagnosis of potentially lethal prostate cancer. This is a diagnostic trial using each patient as his own control.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Elevated PSA | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targeted biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Detection of clinically significant cancer
- timeFrame
- one DAY
- description
- Patient participation is only confined to the biopsy visit.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Men undergoing a first-time prostate biopsy driven by PSA elevation to rule out cancer. * PSA 2.5 - 20 ng/mL * Prostate volume 20 - 100 cc * No prior ablation or TURP * Able to tolerate MRI * T1c suspect * Signed informed consent Exclusion Criteria: * Any prior prostate biopsy * Active bleeding disorder or concurrent use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily stopped for at least 7 days before and 7 days after the biopsy * Any prostate ablative procedure, including transurethral resection, photovaporization, or electrovaporization * Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis) , * Palpable prostate mass lesion (i.e., Stage \>T1c suspected) * Any condition that would preclude the subject from getting the required biopsy as stated in the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.