Status:
COMPLETED
Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
In this study, the investigators intend to validate 18F-DCFPyL test-retest reproducibility in metastatic lesions, in order to investigate whether it serves as a reliable response assessment tool, both...
Detailed Description
The investigators will image patients with widely metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) using 18F-DCFPyL-PET/CT for detection of tumor burden and perfor...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent
- History of histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Patients with metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) with evidence of metastatic disease on conventional imaging with CT or bone scan.
- Prior docetaxel-based chemotherapy is permitted
- Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following and has not initiated a new therapy after determination of progression: Rising PSA over a minimum 1-week interval and/or radiographic progression in soft tissue and bone metastases (combination of bony and soft tissue metastases)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Exclusion
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- 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
- Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
Key Trial Info
Start Date :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03793543
Start Date
March 27 2019
End Date
October 15 2021
Last Update
December 15 2021
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287