Status:
ACTIVE_NOT_RECRUITING
Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Progenics Pharmaceuticals, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 populati...
Detailed Description
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 populati...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 7 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03471650
Start Date
March 29 2018
End Date
March 7 2027
Last Update
March 10 2025
Active Locations (1)
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1
SKCCC
Baltimore, Maryland, United States, 21287