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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: 18F-DCFPyL Injection

• Registration Number: NCT03793543
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 to interpret existing studies and to design future longitudinal trials.

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 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.

Study Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-04
• Study Start: 2019-03-27
• Primary Completion: 2020-03-06
• Status Verified: 2021-03
• Study Completion: 2021-10-15
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-DCFPyL Injection	18F-DCFPyL Injection	9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Primary Outcome Measures

Name	Time	Method
Test the intraobserver agreement as assessed by percentage of scans that are read the same on second read	3 years	The scans of every patient completing the 2 imaging time points will be reread by the same reader about 4 weeks after the first reading.
Change in number of metastatic lesions detected on on 18F-DCFPyL PET/CT from baseline	Change from baseline to up to 4 weeks	Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT at baseline with a subsequent near-term 18F-DCFPyL PET/CT scan.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States