Clinical trial · Interventional
Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer
A Phase II Study to Evaluate the Performance of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer in Men With an Elevated PSA
NCT03471650CI-TRIAL-00106683active not recruitingPhase 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)
This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-DCFPyL Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-DCFPyL Injection
- description
- A bolus of \~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.
- interventionNames
- Drug: 18F-DCFPyL Injection
Primary outcomes (1)
- measure
- Sensitivity of 18F-DCFPyL PET/CT to detect clinically significant prostate cancer on prostate biopsy relative to serum prostate specific antigen (PSA)
- timeFrame
- 4 years
- description
- Measure the diagnostic accuracy of 18F-DCFPyL PET/CT and compare it with serum PSA for detecting clinically significant prostate cancer on prostate biopsy
Secondary outcomes (3)
- measure
- Sensitivity of 18F-DCFPyL PET/CT relative to PSA
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years of age * PSA of 2-10 ng/mL * Clinical stage T1c-T2a on digital rectal exam * Elect to undergo TRUS-guided prostate biopsy as part of routine clinical care * Willingness to sign informed consent and comply with all protocol requirements Exclusion Criteria: * History of prior prostate biopsy * Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT * Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT * Administered oral contrast medium ≤120 hours prior to the date of study PET/CT * Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives
References
Publications (0)
Data not yet available
No reference posted for this study.