The investigators are attempting to determine if a new form of imaging called 18F-DCFPyL PET/CT is helpful to physicians in deciding how to manage suspected prostate cancer recurrence. This imaging uses a Positron Emission Tomography/Computed Tomography (PET/CT) scan using a radioactive tracer 18F-DCFPyL that is concentrated in prostate cancer cells and can potentially identify cancer cells throughout the body. The combination of 18F-DCFPyL PET/CT can potentially identify areas of prostate cancer recurrence not seen with usual imaging \[bone scan, computed tomography (CT) thorax, abdomen and pelvis, plus multi-parametric magnetic resonance imaging (MRI)\].
The study will evaluate the utility of investigational restaging with 18F-DCFPyL PET/CT following conventional imaging (bone scan, CT thorax, abdomen and pelvis plus multi-parametric pelvic MRI) in detecting the prevalence of metastatic disease among men with biochemical recurrence after radical radiotherapy treatment to the prostate. Men treated with primary radiation with external beam or brachytherapy will be eligible. Eighty (80) eligible consenting patients with biochemical recurrence and potentially suitable for local salvage or targeted ablative therapies will be registered and imaged with conventional imaging (bone scan, CT thorax, abdomen and pelvis plus multi-parametric pelvic MRI) followed by investigational restaging with 18F-DCFPyL PET/CT. Characterizing sites of disease identified by the combination of 18F-DCFPyL PET/CT with conventional imaging versus 18F-DCFPyL PET/CT alone will be used to explore the potential of 18F-DCFPyL PET/CT as a single restaging study in men with biochemical recurrence. While further investigation and treatment after restaging will be at the discretion of the investigator and the patient, the actual treatment/management, treatment outcomes and quality of life will be recorded in an electronic database at 6, 12, 24 and 36 months after re-staging. Such longitudinal analyses of management and outcomes will be useful in characterizing the disease trajectory, response to treatment and quality of life for patients whose recurrent disease is managed based on comprehensive restaging using the combination of conventional imaging and 18F-DCFPyL PET/CT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
PET/CT scan using the radioactive agent 18F-DCFPyL
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Toronto Sunnybrook Cancer Centre
Toronto, Ontario, Canada
Detection of extra-prostatic disease
Number of men with extra-prostatic disease detected by either 18F-DCFPyL PET/CT or conventional imaging, divided by the number of men undergoing imaging.
Time frame: 2 weeks post re-staging
Detection of extra-prostatic disease exclusive to 18F-DCFPyl PET/CT
Number of men who have extra-prostatic disease detected exclusively on 18F-DCFPyL PET/CT.
Time frame: 2 weeks post re-staging imaging
Detection of lesions per subject and overall population
The number of extra-prostatic lesions detected by 18F-DCFPyL PET/CT versus conventional imaging alone will be compared on a per subject and overall population basis.
Time frame: 2 weeks post re-staging imaging
Location of extra-prostatic lesions
The location of extra-prostatic lesions detected by 18F-DCFPyL PET/CT versus conventional imaging.
Time frame: 2 weeks post re-staging imaging
Planned treatment management based on re-staging imaging
Planned treatment management based on the information from 18F-DCFPyL PET/CT compared to conventional imaging, to characterize the impact on patient care.
Time frame: 2 weeks post re-staging imaging
Actual treatment management assessed by physician completed study specific questionnaire
A questionnaire developed specifically for the study, called the Post-PET Management Form, will be completed by the attending physician, noting any changes to the treatment based on the results of the 18F-DCFPyL PET/CT imaging. Treatment options may include, but are not limited to, surgery, radiotherapy, androgen deprivation therapy, cryotherapy, and observation.
Time frame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
Disease status (Is the patient alive, deceased, has active disease, or no evidence of disease?)
The investigators want to determine if the patient is alive, deceased, has active disease or no evidence of disease, at approximately yearly intervals. The source of this data could come from physician notes, lab tests, imaging reports, pathology report, or directly from the patient.
Time frame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
Quality of Life
Quality of life is measured using the Functional Assessment of Cancer Therapy - Prostate (FACT-P) and Expanded Prostate Cancer Index Composite (EPIC) standardized questionnaires.
Time frame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
Disease burden measured by serum and urine biomarkers versus imaging
Baseline serum and urine will be obtained for future correlative studies of novel biomarkers of disease burden for comparison against measures of disease burden provided by imaging.
Time frame: Baseline
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