Status:
RECRUITING
18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
Lead Sponsor:
University of Alberta
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations: 1. Adults patients (≥18 years old) with a history of radical prostatectomy for treatme...
Eligibility Criteria
Inclusion Criteria:
- Adult participants (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
- Adult participants with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
- Adult participants with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, brachytherapy, or other similar therapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
- Adult patients who do not meet criteria 1-3 but in whom a 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)
Exclusion Criteria:
- Unable to obtain consent
- Weight > 225 kg (weight limit of PET/CT scanners)
- Unable to lie flat for 30 minutes to complete the PET/CT imaging session
- Lack of intravenous access
- History of allergic reaction to 18F-PSMA-1007
- Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada)
- Less than 18 years old
NOTE: Androgen deprivation therapy (ADT) is NOT a contraindication to participation
Key Trial Info
Start Date :
July 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
2800 Patients enrolled
Trial Details
Trial ID
NCT05520255
Start Date
July 25 2023
End Date
December 1 2029
Last Update
September 23 2025
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3