Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy

Study Overview
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Brief Summary
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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)].

Detailed Description
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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.

Official Title
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Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: 18F-DCFPyL PET/CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous external beam radiotherapy or brachytherapy for localized disease (T1-T2, Gleason < 7 and PSA < 20) or (T1-2, Gleason 8, prostatic specific antigen (PSA)<10) Interval to biochemical failure more than 12 months from last radical therapeutic intervention Biochemical failure confirmed on at least 3 consecutive PSA measurements each taken at least 1 month apart PSA at time of enrollment more than nadir+2.0ng/ml (Phoenix definition of biochemical failure) Karnofsky performance status 70 or better [Eastern Cooperative Oncology Group (ECOG) 0,1] Total serum testosterone level >1nmol/l (if prior treatment with hormone therapy) Exclusion Criteria: CT or bone scan within 6 months of enrollment Patients whose prior radiotherapy was delivered with palliative intent Patients with known metastatic disease Extensive co-morbidities precluding potential ablative salvage procedures Prior history of invasive non-cutaneous malignant disease unless disease free for at least 5 years Already on systemic anticancer treatment (androgen deprivation or chemotherapy) Inability to comply with the imaging requirements e.g. inability to lie supine for one hour Allergy or contraindication to MRI or CT contrast agents or PET tracer to be used as part of the imaging Insufficient renal function [estimated glomerular filtration rate (eGFR) < 30 mL/min]

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: Intervention 18F-DCFPyL PET/CT<br>18F-DCFPyL PET/CT scan obtained at the time of restaging for biochemical recurrence after primary radiotherapy | Radiation: 18F-DCFPyL PET/CT scan<br>* PET/CT scan using the radioactive agent 18F-DCFPyL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks post re-staging | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline |