Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers

Study Overview
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Brief Summary
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Primary Objective: To determine whether changes in uptake of [18F]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria. Secondary Objectives: To determine whether changes in uptake of [18F]DCFPyL PET/CT scans correlate with overall survival (OS) To determine whether baseline SUVmax correlate with rPFS To compare number of lesions detected with standard imaging at baseline and at the time of progression

Detailed Description
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Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy. PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

Official Title
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Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers

Conditions
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Metastatic Prostate Cancer

Intervention / Treatment
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* Drug: [F-18] DCFPyL
* Procedure: PET/CT imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of prostate cancer Age ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3 Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease Ability to understand and willingness to sign a written informed consent document Wiling 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 Administration of another radioisotope within five physical half-lives of trial enrollment Radiation or chemotherapy within 2 weeks prior to trial enrollment Serum creatinine > 3 times the upper limit of normal Serum total bilirubin > 3 times the upper limit of normal Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >5 times the upper limit of normal Inadequate venous access

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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Fifteen men will be recruited from Columbia University Medical Center.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PyL-PET<br>Male participants diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment will receive [F-18] DCFPyL PET/CT imaging before starting new treatment and after 6 weeks on treatment. | Drug: [F-18] DCFPyL<br>* [18F]DCFPyL will be used for study imaging. It will be administered intravenously on the day of imaging. Subjects will receive a bolus injection of 9mCi (331 MBq) of [18F]DCFPyL through a peripheral IV catheter. 60 to 120 minutes after injection, a whole body (toes to vertex) lowdose CT will be obtained (120 kVp, 80 mA maximum).<br>* Other names: [18F]DCFPyL (PyL);Procedure: PET/CT imaging<br>* As per standard of care, acquisition will be performed on PET/CT scanner (Siemens, Germany) operating in 3D emission mode with CT-derived attenuation correction.<br>* Other names: PET/CT acquisition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS) | To determine if changes in PyL PET/CT scans before and after 6 weeks on treatment is associated with stability of disease as measured by standard imaging. | Baseline, Post-treatment (approximately 6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of changes in uptake of [18F]DCFPyL PET/CT scans correlating with Overall Survival (OS) | The percent difference in summed SUV between the first and second PET/CT will be noted. | Baseline, Post-treatment (approximately 6 weeks) | 
| Prevalence of baseline SUVmax correlating with rPFS | To determine if standardized uptake values (SUVs) at baseline is a good measure for patient evaluation. | Baseline, Post-treatment (approximately 6 weeks) | 
| Change in number of lesions detected with standard imaging at baseline and at the time of progression | To compare lesions detected with standard imaging | Baseline, up to 1 year |