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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 18F-DCFPyL Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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J18127 PSMA PyL 18F-DCFPyL PET/CT