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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 18F-DCFPyL Injection

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-DCFPyL Injection; 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL	Drug: 18F-DCFPyL Injection; A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Steven Rowe, M.D., Ph.D., Johns Hopkins University

Publications and helpful links

General Publications

• Werner RA, Habacha B, Lutje S, Bundschuh L, Higuchi T, Hartrampf P, Serfling SE, Derlin T, Lapa C, Buck AK, Essler M, Pienta KJ, Eisenberger MA, Markowski MC, Shinehouse L, AbdAllah R, Salavati A, Lodge MA, Pomper MG, Gorin MA, Bundschuh RA, Rowe SP. High SUVs Have More Robust Repeatability in Patients with Metastatic Prostate Cancer: Results from a Prospective Test-Retest Cohort Imaged with 18F-DCFPyL. Mol Imaging. 2022 Feb 23;2022:7056983. doi: 10.1155/2022/7056983. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Actual): March 6, 2020
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: J18127 PSMA PyL 18F-DCFPyL PET/CT
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: J18127; IRB00174393 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No