There are several new therapies available to treat men with advanced prostate cancer; however, the decision making tools needed to determine the best treatment for these patients are noticeably absent. The prostate-specific membrane antigen (PSMA) is increasingly being recognized as an important target for prostate cancer imaging and determining the most effective therapy. Accordingly, a wide variety of agents are being used to image PSMA. One of these agents is 18F-DCFPyL. In this study the investigators will image men with advanced prostate cancer using 18F-DCFPyL and a positron emission computed tomography (PET/CT) scanner. The investigators will compare the results of 18F-DCFPyL PET/CT for the detection of metastases and monitoring the effects of therapy with conventional imaging (CT, bone scan) and clinical follow-up. In this way, the investigators will evaluate the benefit of using 18F-DCFPyL PET/CT to decide what is the best treatment strategy for a man with advanced prostate cancer.
This is an exploratory single centre, non-randomized, open-label, study in male subjects with metastatic, castrate-resistant PCa (CRPC) being treated with a second-line anti-androgen therapy (enzalutamide or abiraterone). The purpose of the study is to assess if 18F-DCFPyL PET/CT: 1. Shows more sites of metastatic, castrate-resistant PCa (CRPC) compared with standard imaging (bone scan and CT) at baseline and follow-up, 2. Shows response to therapy that is associated with clinical outcome. This study will image male subjects with CRPC undergoing second-line anti-androgen therapy (enzalutamide or abiraterone) using 18F-DCFPyL PET/CT for detection of metastases and therapeutic monitoring, with correlation to standard-of-care imaging (CT and bone scan) and clinical follow-up over a 1-year time period. Subjects with CRPC and planned treatment with evidence of metastases on standard-of-care imaging (CT and/or bone scan) will undergo a baseline and mid-therapy 18F-DCFPyL PET/CT. The study design consists of three study clinic visits (screening, baseline 18F-DCFPyL PET/CT, and 8-14 week follow-up 18F-DCFPyL PET/CT) and two follow-up safety phone calls. In addition, all subjects will be followed clinically as per local standard of care with prostate-specific antigen (PSA) blood levels and standard of care imaging for up to one year following the baseline 18F-DCFPyL administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
18F-DCFPyL is a sterile diagnostic radiopharmaceutical used for PET imaging.
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Number of participants with [F-18]-DCFPyL-related adverse events as assessed by CTCAE v4.0
The safety of \[F-18\]-DCFPyL administration to participants will be assessed by measuring changes from baseline in vital signs (blood pressure, heart rate and oxygen saturation) on the day of injection and through documentation of any other reported adverse events for up to 3 days post-administration.
Time frame: Up to 3 days post [F-18]-DCFPyL Injection
Extent of baseline disease on [F-18]-DCFPyL imaging compared to extent of baseline disease on conventional imaging in each participant as assessed by counting the total number of lesions on imaging prior to starting hormonal therapy
The extent of baseline disease on \[F-18\]-DCFPyL imaging (total number of lesions) will be compared to the extent of baseline disease on conventional imaging (total number of lesions) to determine \[F-18\]-DCFPyL imaging sensitivity.
Time frame: At the time of initial imaging
Treatment response on [F-18]-DCFPyL imaging using EORTC criteria will be compared with treatment response on clinical follow-up according to PCWG2 criteria.
Time frame: 1 year post hormonal therapy initiation
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