Clinical trial · Interventional
PSMA PET Scan and mpMRI for Prostate Cancer Detection
Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer
NCT05820724CI-TRIAL-00065902unknownPhase 2ClinicalTrials.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)
Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone.
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 Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F- DCFPyl Injection | Drug | — | UNRESOLVED |
| No PSMA PET | Other | — | UNRESOLVED |
| PSMA PET scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PSMA PET+mpMRI
- description
- PSMA PET+mpMRI guided prostate biopsy
- interventionNames
- Diagnostic Test: PSMA PET scan
- Drug: 18F- DCFPyl Injection
- type
- ACTIVE_COMPARATOR
- label
- mpMRI only
- description
- mpMRI only guided prostate biopsy
- interventionNames
- Other: No PSMA PET
Primary outcomes (1)
- measure
- Detection of Clinically Significant Prostate Cancer
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with PI-RADS 4-5 lesion(s) on mpMRI and have elected to undergo a prostate biopsy * Prostate mpMRI completed within 9 months prior to enrollment * Patient capable of providing written informed consent * Patient willing to be randomized to prostate mpMRI only vs prostate mpMRI + DCFPyL PET/CT Exclusion Criteria: * Less than 18 years-old at the time of radiotracer administration * Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance. * Creatinine clearance exceeding institutional requirements for prostate mpMRI
References
Publications (0)
Data not yet available
No reference posted for this study.