Clinical trial · Interventional
PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer
Phase II Study to Evaluate the Performance of PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Clinically Significant Prostate Cancer in Men Presenting Following a Positive Screen for Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study aborted
Summary
Brief summary (as posted)
This phase II trial studies how well 18F-DCFPyL positron emission tomography (PET)/magnetic resonance imaging (MRI) works for the diagnosis of prostate cancer in men with a PSA greater than or equal to 2 ng/mL. 18F-DCFPyl is a radioactive injectable imaging agent made of a prostate specific membrane antigen (PSMA) that attaches to tumor cells, which makes it useful for the diagnosis of prostate cancer. A PET scan is an imaging tool that may help find the location of cancer, by using a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. A mp-MRI is used to help determine the extent of a patient's cancer. A MRI scan uses strong magnets and computers to create detailed images of the soft tissue in the body. This trial aims to compare PET scans to prostate specific mp-MRI to evaluate prostate cancer severity in men with a positive screen for prostate cancer.
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 Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorine F 18 DCFPyL | Drug | — | UNRESOLVED |
| Gadobenate Dimeglumine | Drug | — | UNRESOLVED |
| Gadobutrol | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Multiparametric Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Transrectal Ultrasonography Guided Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (18F-DCFPyL PET/MRI, mpMRI)
- description
- Patients receive fluorine F 18 DCFPyL IV and undergo PET/MRI. Patients also receive either gadobutrol IV or gadobenate dimeglumine IV (per radiologist preference), and undergo mpMRI. Within approximately 60 days after PET/MRI and mpMRI, patients undergo TRUS guided prostate biopsy per standard of care.
- interventionNames
- Drug: Fluorine F 18 DCFPyL
- Drug: Gadobenate Dimeglumine
- Drug: Gadobutrol
- Procedure: Magnetic Resonance Imaging
- Procedure: Multiparametric Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Procedure: Transrectal Ultrasonography Guided Biopsy
Primary outcomes (1)
- measure
- 18-F-DCFPyL positron emission tomography (PET) vs multiparametric magnetic resonance imaging (mpMRI) for the diagnosis of clinically significant prostate cancer in biopsy naïve men.
- timeFrame
- Up to 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a positive screen for prostate cancer as confirmed by a prostate specific antigen (PSA) \>= 2 ng/ml * Patients must elect to elect to undergo PHI blood test and TRUS-guided elect to undergo PHI blood test and TRUS-guided biopsy as part of routine clinical care * Patients must be age \>= 18 years * Patients must agree to use adequate contraception (e.g. Barrier method of birth control; abstinence) for 24 hours following completion of imaging * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study Exclusion Criteria: * Patients who have had a prior biopsy for prostate cancer * Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments) are not eligible * Patients receiving any other treatments or investigational agents are not eligible * Patients with a glomerular filtration rate (GFR) \< 30mL/min are ineligible to receive intravenous contrast per standard magnetic resonance (MR) exclusion criteria * Patients administered a radioisotope \< 5 physical half-lives prior to the date of study PET/MRI * Patients administered IV X-ray contrast medium \< 120 hours prior to the date of study PET/MRI * Patients who report taking multivitamins on the day of study PET/MRI
References
Publications (0)
Data not yet available