Status:
ENROLLING_BY_INVITATION
Prostate Cancer Patient Management With 18F-DCFPyL PET/CT
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedu...
Detailed Description
Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a centr...
Eligibility Criteria
Inclusion
- Male sex
- Age 18 years or older
- Previously diagnosed with prostate cancer, under referring physician's care
- ECOG performance status 0 - 3, inclusive
- Able to understand and provide written informed consent
- Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection
- Cohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following:
- Gleason score \> 7
- Serum PSA \> 15 ng/ml
- T stage of T3 or greater on TNM staging
- Equivocal/inconclusive conventional staging such as CT, MRI or bone scan
- Clinical suspicion of advance stage disease (e.g. bone pain)
- Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer.
Exclusion
- Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
- Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
- Patients with unmanageable claustrophobia
Key Trial Info
Start Date :
June 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT03459820
Start Date
June 22 2018
End Date
June 1 2028
Last Update
November 27 2023
Active Locations (1)
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1
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2