Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
This is a multi-reader methodological study comparing the diagnostic value of 68Ga-PSMA-HBED-CC PET/CT or 68Ga-PSMA-HBED-CC PET/MRI over MRI alone, using histologic confirmation or serial follow-up for up to 2 years as the gold standard for determination of primary prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this will demonstrate the superiority of 68Ga-PSMA-HBED-CC PET to MRI for sensitivity, and the non-inferiority of 68Ga-PSMA-HBED-CC PET to MRI for specificity.This is a paired, case-control design that is appropriate to statistically evaluate the difference in sensitivity and specificity between the two imaging modalities. Therefore, the estimation of population prevalence is not a study objective, and estimation of clinical utility through calculation of positive and negative predictive values is not appropriate. Imaging studies and follow up subject scans will be organized so that a panel of independent readers will evaluate the MRI and PET studies to assess the level of suspicion for prostate cancer.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: PET/MRI 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. |
Drug: PET/MRI with Gallium-68 labeled PSMA-HBED-CC
Subjects have one visit, during which they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical
|
Experimental: Multiple PET/MRI 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. |
Drug: Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC
Subjects have two visits (the second visit being optional) within two years. During each visit, they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical
|
Experimental: PET/CT PET/CT with Gallium-68 labeled PSMA-HBED-CC: Subjects will have one visit during which they will undergo a PET/CT after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC. |
Drug: PET/CT with Gallium-68 labeled PSMA-HBED-CC
Subjects have one visit, during which they will undergo one PET/CT with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and specificity, of 68Ga-PSMA-HBED-CC PET [Up to two time points (approx. 2 hours each) within 3 years or less]
Compare the diagnostic performance, presented as comparative sensitivity and specificity, of 68Ga-PSMA-HBED-CC PET versus conventional MRI in a population of patients with prostate cancer.
Secondary Outcome Measures
- Safety of the 68Ga-PSMA-HBED-CC [Up to two time points (approx. 2 hours each) within 3 years or less]
To be assessed by tabulation of number of procedure-related adverse effects
Eligibility Criteria
Criteria
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Male aged 21 years or older.
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Ability to provide signed informed consent and willingness to comply with protocol requirements.
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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).
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Meet one of the following 5 criteria
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Planned for surgical extirpation, which may or may not include lymph node dissection (high risk primary disease)
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Planned for targeted biopsy of primary lesion
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Conventional imaging equivocal or suggestive of prostate cancer metastasis/es
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Planned focal therapy (with or without radiation therapy) with serial follow-up
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Elevated PSA with no conventional imaging suggestive of metastatic or recurrent disease
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- 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.
- 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:
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Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MRI.
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If part of PET/MRI cohort and patient cohort 3 or 5, subject does not plan to have a prescribed abdomen and pelvis MRI
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If part of PET/MRI cohort and patient cohort 1, 2 or 4, subject does not plan to have a prescribed pelvis MRI
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If part of PET/CT cohort and patient cohort 3 or 5, subject does not have previous MR imaging of abdomen and pelvis
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If part of PET/CT cohort and patient cohort 1, 2 or 4, subject does not have previous MR imaging of pelvis
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If part of PET/CT cohort, investigator review determines that previous MR images do not meet institutional quality standards
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If part of PET/MRI cohort, contraindications to MRI
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Contraindications to PSMA IV administration
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Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Weill Cornell Medical College | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
- Cancer Research & Treatment Fund, Inc
Investigators
- Principal Investigator: John W. Babich, Ph.D., Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1706018301