Prostate Cancer Patient Management With 18F-DCFPyL PET/CT

Study Overview
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Brief Summary
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This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.

Detailed Description
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Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts. Primary endpoint: 1. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts. Secondary endpoints: 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.

Official Title
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Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: 18F-DCFPyL PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male sex Age 18 years or older Previously diagnosed with prostate cancer, under referring physician's care ECOG performance status 0 - 3, inclusive Able to understand and provide written informed consent Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection Cohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following: Gleason score > 7 Serum PSA > 15 ng/ml T stage of T3 or greater on TNM staging Equivocal/inconclusive conventional staging such as CT, MRI or bone scan Clinical suspicion of advance stage disease (e.g. bone pain) Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer. Exclusion Criteria: Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter) Patients with unmanageable claustrophobia

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 PET/CT<br>18F-DCFPyL PET/CT Scan | Diagnostic Test: 18F-DCFPyL PET/CT<br>* 18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in optimal clinical management | Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scan positivity fraction in BCR by PSA. | 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA. | 30 days | 
| Adverse events | Immediate AE up to 90 minutes post-administration of 18F-DCFPyL. | 2 hours |