Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy

Prostate Cancer Clinical Trial

— PICs  

Official title:

Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793284
• Other study ID #: PICs
• Status: Completed
• Phase: N/A
• Start date: January 9, 2017
• Est. completion date: February 15, 2022

Study information

• Verified date: March 2022
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)].

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 15, 2022
• Est. primary completion date: June 19, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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]

Related Conditions & MeSH terms

• Prostate Cancer
• Recurrence

Intervention

Radiation:
• 18F-DCFPyL PET/CT scan
PET/CT scan using the radioactive agent 18F-DCFPyL

Locations

Country	Name	City	State
Canada	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

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Ontario Institute for Cancer Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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