Clinical trial NCT03793543: Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients With Metastatic Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: J18127 PSMA PyL 18F-DCFPyL PET/CT
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in number of metastatic lesions detected on on 18F-DCFPyL PET/CT from baseline
timeFrame: Change from baseline to up to 4 weeks
measure: Test the intraobserver agreement as assessed by percentage of scans that are read the same on second read
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steven Rowe, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.