Study Results
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Basic Information
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RECRUITING
NA
3070 participants
INTERVENTIONAL
2018-09-27
2025-12-31
Brief Summary
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Detailed Description
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PREP Phase 2 was initiated to investigate the hypothesis that conventional imaging is not adding to the information provided by PSMA PET/CT alone. PREP Phase 2 will retain the same study design as Phase I but will remove bone scan and computed tomography as criteria for entry into the study except for those patients with higher PSA (\>10 ng/ml).
Identical cohort sizes will be accrued in Phase 2 to permit comparison of detection rates with similar confidence intervals with and without conventional imaging. Transition to PREP Phase 2 occurred when overall accrual to PREP exceeded 80% of target.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort 1
Men who are node positive or who have persistently detectable PSA after initial radical prostatectomy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)
[18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with \[18F\]-DCFPyL PET/CT Scan (PSMA PET).
Cohort 2
Men with biochemical failure after initial prostatectomy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)
[18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with \[18F\]-DCFPyL PET/CT Scan (PSMA PET).
Cohort 3
Men with biochemical failure after initial radical prostatectomy and salvage radiotherapy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)
[18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with \[18F\]-DCFPyL PET/CT Scan (PSMA PET).
Cohort 4
Men with biochemical failure after initial radical prostatectomy with or without adjuvant/ salvage radiotherapy who are currently on salvage hormone therapy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)
[18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with \[18F\]-DCFPyL PET/CT Scan (PSMA PET).
Cohort 5
Men who have prior PSMA directed treatment for oligometastatic disease, such as lesion directed therapy (e.g. stereotactic radiosurgery) or systemic therapy (e.g. hormone therapy or chemotherapy) with subsequent biochemical failure will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)
[18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with \[18F\]-DCFPyL PET/CT Scan (PSMA PET).
Cohort 6
Men with biochemical failure after primary radiation therapy (external beam, brachytherapy or combinations together with or without hormone therapy) will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)
[18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with \[18F\]-DCFPyL PET/CT Scan (PSMA PET).
Cohort 7
\[18F\]-DCFPyL as a problem-solving tool in patients with prostate cancer when confirmation of the site of disease and/or disease extent may impact clinical management. Patients in this cohort require approval from an independent adjudication by Cancer Care Ontario.
[18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with \[18F\]-DCFPyL PET/CT Scan (PSMA PET).
Interventions
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[18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with \[18F\]-DCFPyL PET/CT Scan (PSMA PET).
Eligibility Criteria
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Inclusion Criteria
2. Male, Age ≥ 18 years
3. Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer. Unless PET/CT requested as part of Cohort 7.
4. Suspected persistent or recurrent disease defined as one of the following (unless PET/CT requested as part of Cohort 7):
1. High risk disease at the time of radical prostatectomy characterized by pathologically involved node(s) or persistently detectable PSA (\>0.1ng/ml) within 3 months post-surgery
2. Primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following:
i. Following primary radical prostatectomy, BF is defined as rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured at \>0.1 ng/ml
ii. Following primary radiotherapy for localized disease, BF is defined according to the Phoenix Definition, which is rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured greater than the nadir PSA + 2.0 ng/ml
5. Patient scenario falls into one of the 7 pre-defined cohorts. When patient scenario falls outside cohorts 1-6 participation in the Registry must be approved through the established CCO adjudication process for Cohort 7.
6. Karnofsky performance status 70 or better (ECOG 0, 1).
7. If PSA \>10 mg/mL, conventional imaging consisting of bone scan and abdo-pelvic CT scan within 3 months of registration that is either equivocal, negative (no lesions) or positive for oligometastatic disease (4 or fewer unequivocal lesions identified).
Exclusion Criteria
2. Prior PSMA PET scan within 6 months of enrollment.
3. Patient cannot lie still for at least 60 minutes or comply with imaging.
4. Patients falling outside of Cohorts 1-6 where independent adjudication by CCO does not support participation in the Registry.
18 Years
MALE
No
Sponsors
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Cancer Care Ontario
OTHER
Centre for Probe Development and Commercialization
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Glenn Bauman, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Ur Metser, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Toronto Sunnybrook Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre, University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Catherine Hildebrand, PhD, Project Coordinator
Role: CONTACT
Facility Contacts
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Clinical Trial Coordinator- Marlene Kebabdjian
Role: primary
References
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Basso Dias A, Finelli A, Bauman G, Veit-Haibach P, Berlin A, Ortega C, Avery L, Metser U. Impact of 18F-DCFPyL PET on Staging and Treatment of Unfavorable Intermediate or High-Risk Prostate Cancer. Radiology. 2022 Sep;304(3):600-608. doi: 10.1148/radiol.211836. Epub 2022 May 24.
Metser U, Zukotynski K, Mak V, Langer D, MacCrostie P, Finelli A, Kapoor A, Chin J, Lavallee L, Klotz LH, Hagerty M, Hildebrand C, Bauman G. Effect of 18F-DCFPyL PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial. Radiology. 2022 May;303(2):414-422. doi: 10.1148/radiol.211824. Epub 2022 Jan 25.
Other Identifiers
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4826
Identifier Type: -
Identifier Source: org_study_id
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