Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer

Johns Hopkins Medicine

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: 18F-DCFPyL Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03793543

J18127

IRB00174393 (Other Identifier)

Details and patient eligibility

About

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 to interpret existing studies and to design future longitudinal trials.

Full 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 perform a lesion-based head-to-head comparison with a subsequent near-term (one to seven days) 18F-DCFPyL-PET/CT follow-up scan, to assess test-retest reproducibility of this second-generation PSMA-targeted compound. Second, as it has not been specifically investigated with this compound before, intra-observer agreement as well as inter-scan variability will be assessed.

Enrollment

23 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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