Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

Study Overview
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Brief Summary
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This study evaluates the rate of radiological disease progression with the new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, in patients with metastatic castration (mCRPC) and non-metastatic (nmCRPC) castration resistant prostate cancer who have evidence of biochemical (PSA) disease progression without evidence of radiological disease progression on conventional standard radiologic testing (99mTc-methylene diphosphonate bone scan and CT).

Official Title
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Study of 18F-DCFPyL PET/CT, for Detection of Radiological Progression in Patients With Metastatic (M+) and Non-metastatic (M0) Castration Resistant Prostate Cancer Receiving Standard Androgen Receptor Targeted Treatment

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: Histological confirmation of prostate cancer Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration. Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both) Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months. Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart) PSADT ≤ 9 months Cohort B: mCRPC Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted). PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility. No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Exclusion Criteria: Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging

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>A single dose of 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>* Other names: PyL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer | Proportion of patients demonstrating disease progression by conventional criteria evaluated by CT scan and 99mTc-methylene diphosphonate bone scan and on 18F-DCFPyL PET/CT. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality | Number of lesions detected on 18F-DCFPyL PET/CT in comparison to number of lesions detected on conventional imaging (99mTc-methylene diphosphonate bone scan and CT) | 3 years | 

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