Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy (PICs)
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|ClinicalTrials.gov Identifier: NCT02793284|
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : March 28, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: 18F-DCFPyL PET/CT scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Advanced Prostate Imaging of Recurrent Cancer After Radiotherapy|
|Actual Study Start Date :||January 9, 2017|
|Actual Primary Completion Date :||June 19, 2018|
|Actual Study Completion Date :||February 15, 2022|
Experimental: Intervention 18F-DCFPyL PET/CT
18F-DCFPyL PET/CT scan obtained at the time of restaging for biochemical recurrence after primary radiotherapy
Radiation: 18F-DCFPyL PET/CT scan
PET/CT scan using the radioactive agent 18F-DCFPyL
- Detection of extra-prostatic disease [ Time Frame: 2 weeks post re-staging ]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.
- Detection of extra-prostatic disease exclusive to 18F-DCFPyl PET/CT [ Time Frame: 2 weeks post re-staging imaging ]Number of men who have extra-prostatic disease detected exclusively on 18F-DCFPyL PET/CT.
- Detection of lesions per subject and overall population [ Time Frame: 2 weeks post re-staging imaging ]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.
- Location of extra-prostatic lesions [ Time Frame: 2 weeks post re-staging imaging ]The location of extra-prostatic lesions detected by 18F-DCFPyL PET/CT versus conventional imaging.
- Planned treatment management based on re-staging imaging [ Time Frame: 2 weeks post 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.
- Actual treatment management assessed by physician completed study specific questionnaire [ Time Frame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging ]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.
- Disease status (Is the patient alive, deceased, has active disease, or no evidence of disease?) [ Time Frame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging ]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.
- Quality of Life [ Time Frame: 6 months, 12 months, 24 months, and 36 months after re-staging imaging ]Quality of life is measured using the Functional Assessment of Cancer Therapy - Prostate (FACT-P) and Expanded Prostate Cancer Index Composite (EPIC) standardized questionnaires.
- Disease burden measured by serum and urine biomarkers versus imaging [ Time Frame: Baseline ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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)
- 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]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793284
|Hamilton Health Sciences Centre|
|Hamilton, Ontario, Canada|
|London Regional Cancer Program of the Lawson Health Research Institute|
|London, Ontario, Canada, N6A 4L6|
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada|
|Toronto Sunnybrook Cancer Centre|
|Toronto, Ontario, Canada|
|Principal Investigator:||Glenn Bauman, MD||London Regional Cancer Program of the Lawson Health Research Institute|
|Responsible Party:||Glenn Bauman, Principal Investigator, Lawson Health Research Institute|
|Other Study ID Numbers:||
|First Posted:||June 8, 2016 Key Record Dates|
|Last Update Posted:||March 28, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|