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

Prostate Cancer Clinical Trial

Official title:

Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer - an Interscan Variability and Intraobserver Agreement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793543
• Other study ID #: J18127
• Secondary ID: IRB00174393
• Status: Completed
• Phase: Phase 1
• Start date: March 27, 2019
• Est. completion date: October 15, 2021

Study information

• Verified date: March 2021
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 15, 2021
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 18F-DCFPyL Injection
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of metastatic lesions detected on on 18F-DCFPyL PET/CT from baseline	Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT at baseline with a subsequent near-term 18F-DCFPyL PET/CT scan.	Change from baseline to up to 4 weeks
Primary	Test the intraobserver agreement as assessed by percentage of scans that are read the same on second read	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.	3 years