Status:
TERMINATED
Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Cancer Research & Treatment Fund, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
21+ years
Phase:
PHASE2
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 ...
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 fo...
Eligibility Criteria
Inclusion
- Male aged 21 years or older.
- Ability to provide signed informed consent and willingness to comply with protocol requirements.
- 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).
- Meet one of the following 5 criteria
- Planned for surgical extirpation, which may or may not include lymph node dissection (high risk primary disease)
- Planned for targeted biopsy of primary lesion
- Conventional imaging equivocal or suggestive of prostate cancer metastasis/es
- Planned focal therapy (with or without radiation therapy) with serial follow-up
- Elevated PSA with no conventional imaging suggestive of metastatic or recurrent disease
- 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.
- 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:
- Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MRI.
- If part of PET/MRI cohort and patient cohort 3 or 5, subject does not plan to have a prescribed abdomen and pelvis MRI
- If part of PET/MRI cohort and patient cohort 1, 2 or 4, subject does not plan to have a prescribed pelvis MRI
- If part of PET/CT cohort and patient cohort 3 or 5, subject does not have previous MR imaging of abdomen and pelvis
- If part of PET/CT cohort and patient cohort 1, 2 or 4, subject does not have previous MR imaging of pelvis
- If part of PET/CT cohort, investigator review determines that previous MR images do not meet institutional quality standards
- If part of PET/MRI cohort, contraindications to MRI
- Contraindications to PSMA IV administration
- Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment
Exclusion
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2021
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT03439033
Start Date
April 3 2018
End Date
May 5 2021
Last Update
March 13 2023
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10021