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

NCT03793543 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: J18127IRB00174393
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

J18127 PSMA PyL 18F-DCFPyL PET/CT

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

18F-DCFPyL Injection

EXPERIMENTAL

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

Drug: 18F-DCFPyL Injection

Interventions

18F-DCFPyL Injection DRUG

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

18F-DCFPyL Injection

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Werner RA, Lutje S, Habacha B, Bundschuh L, Higuchi T, Buck AK, Kosmala A, Lapa C, Essler M, Lodge MA, Pienta KJ, Eisenberger MA, Markowski MC, Gorin MA, Pomper MG, Rowe SP, Bundschuh RA. Test-retest repeatability of organ uptake on PSMA-targeted 18 F-DCFPyL PET/CT in patients with prostate cancer. Prostate. 2023 Sep;83(12):1186-1192. doi: 10.1002/pros.24577. Epub 2023 May 21.

  PMID: 37211963 DERIVED

• 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.

  PMID: 35283693 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Steven Rowe, M.D., Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: March 27, 2019
• Primary Completion: March 6, 2020
• Study Completion: October 15, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)