Clinical trial · Interventional
Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer
A Phase 2 Comparison Study of 68Ga-PSMA-HBED-CC Positron Emission Tomography (PET)/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer
NCT03439033CI-TRIAL-00064630terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 Drug was FDA approved Summer 2021
Summary
Brief summary (as posted)
This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men with prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this comparison will demonstrate that PET using the tracer, 68Ga-PSMA-HBED-CC, is more sensitive than MRI alone. Potential subjects who cannot undergo MRI may undergo PET/CT instead.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC | Drug | — | UNRESOLVED |
| PET/CT with Gallium-68 labeled PSMA-HBED-CC | Drug | — | UNRESOLVED |
| PET/MRI with Gallium-68 labeled PSMA-HBED-CC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- PET/MRI
- description
- PET/MRI with Gallium-68 labeled PSMA-HBED-CC: Subjects will have one visit during which they will undergo a PET/MRI after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC.
- interventionNames
- Drug: PET/MRI with Gallium-68 labeled PSMA-HBED-CC
- type
- EXPERIMENTAL
- label
- Multiple PET/MRI
- description
- Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC: Subjects will be invited to participate in two visits within two years, the second being an optional visit. During each visit, subjects will undergo a PET/MRI after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC. This arm will be restricted to subjects who plan to undergo focal therapy.
- interventionNames
- Drug: Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC
- type
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
1. Male aged 21 years or older. 2. Ability to provide signed informed consent and willingness to comply with protocol requirements. 3. Pathologic confirmation of adenocarcinoma of the prostate gland or high clinical suspicion (PSA \> 4 ng/mL, or PSA density \> 0.15 ng/mL2, or PSA doubling time \< 2 years). 4. Meet one of the following 5 criteria 1. Planned for surgical extirpation, which may or may not include lymph node dissection (high risk primary disease) 2. Planned for targeted biopsy of primary lesion 3. Conventional imaging equivocal or suggestive of prostate cancer metastasis/es 4. Planned focal therapy (with or without radiation therapy) with serial follow-up 5. Elevated PSA with no conventional imaging suggestive of metastatic or recurrent disease 5. a. If part of PET/MRI cohort, subject will undergo clinically indicated MRI imaging prior to treatment. Or b. If part of PET/CT cohort, subject will have had clinically indicated MRI within 3 months prior to treatment. 6. Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after each injection, if engaged in sexual activity. Exclusion Criteria: 1. Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MRI. 2. If part of PET/MRI cohort and patient cohort 3 or 5, subject does not plan to have a prescribed abdomen and pelvis MRI 3. If part of PET/MRI cohort and patient cohort 1, 2 or 4, subject does not plan to have a prescribed pelvis MRI 4. If part of PET/CT cohort and patient cohort 3 or 5, subject does not have previous MR imaging of abdomen and pelvis 5. If part of PET/CT cohort and patient cohort 1, 2 or 4, subject does not have previous MR imaging of pelvis 6. If part of PET/CT cohort, investigator review determines that previous MR images do not meet institutional quality standards 7. If part of PET/MRI cohort, contraindications to MRI 8. Contraindications to PSMA IV administration 9. Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.