Clinical trial NCT02793284: Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy
Official title: Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ontario Institute for Cancer Research
First posted: 2016-06-08
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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 \[estimated glomerular filtration rate (eGFR) \< 30 mL/min\]

Primary outcomes:
measure: Detection of extra-prostatic disease
timeFrame: 2 weeks post re-staging
Secondary outcomes:
measure: Detection of extra-prostatic disease exclusive to 18F-DCFPyl PET/CT
timeFrame: 2 weeks post re-staging imaging
measure: Detection of lesions per subject and overall population
timeFrame: 2 weeks post re-staging imaging
measure: Location of extra-prostatic lesions
timeFrame: 2 weeks post re-staging imaging
measure: Planned treatment management based on re-staging imaging
timeFrame: 2 weeks post re-staging imaging
measure: Actual treatment management assessed by physician completed study specific questionnaire
timeFrame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
measure: Disease status (Is the patient alive, deceased, has active disease, or no evidence of disease?)
timeFrame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
measure: Quality of Life
timeFrame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging
measure: Disease burden measured by serum and urine biomarkers versus imaging
timeFrame: Baseline
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program of the Lawson Health Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Cancer Centre
state: Ontario
Study officials:
affiliation: London Regional Cancer Program of the Lawson Health Research Institute
name: Glenn Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References: