18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

Study Overview
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Brief Summary
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This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.

Detailed Description
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This is an trial designed to evaluate the positive predictive value of 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing PSA levels. Patients will receive a single dose of 18FDCFPyL PET and undergo a PET imaging study. 18F-DCFPyL Injection is an 18F-labeled small molecule that targets the extracellular domain of PSMA. One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with ≤ 333 MBq (≤ 9 mCi) of 18F-DCFPyL via this catheter. The dose range for 18F-DCFPyL will be 7 - 9 mCi. The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.

Official Title
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Phase 2 Study of 18F-DCFPyL Positron Emission Tomography (PET) in Men With Intermediate or High Risk Biochemically Recurrent Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 18F-DCFPyL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of prostate cancer Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6 weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following radiation therapy (ASTRO Phoenix consensus definition) Age ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) Ability to understand and willingness to sign a written informed consent document Willing to comply with clinical trial instructions and requirements Exclusion Criteria: History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin Presence of prostate brachytherapy implants unless approved by the PI Administration of another radioisotope within five physical half-lives of trial enrollment Radiation or chemotherapy within 2 weeks prior to trial enrollment Estimated glomerular filtration rate (eGFR) < 15 ml/mmol Serum total bilirubin > 3 times the upper limit of normal Aspartate transaminase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of normal Inadequate venous access Claustrophobia or any other condition that would preclude PET imaging Patients must not be receiving ADT except per criteria directly below. Patients who received in the past must have a serum testosterone that is recovered to at least 100 ng/dL. Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC

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 imaging<br>Participants will receive a single dose of 18F-DCFPyL and undergo a PET imaging study. (The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.) | Drug: 18F-DCFPyL<br>* 18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value (PPV) (per-patient) | Number of patients with true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without disease). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value (PPV) (per-region) | Number of true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without true disease), by region (prostate bed, locoregional lymph nodes, distant lymph nodes, bones, and/or visceral organs). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake. | Up to 12 months |