Status:
COMPLETED
18F-PSMA-1007 PET/CT Imaging in Patients with Biochemically Recurrent or High-risk Prostate Cancer
Lead Sponsor:
University of Alberta
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in patients with biochemically recurrent or high-risk prostate cancer. Safety, biodistribution, clinical efficacy, and d...
Detailed Description
A single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in specific patient populations: 1. Adult patients (≥ 18 years old) with a history of radical prostatectomy for treat...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) \> 0.2 µg/L
- Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of \< 9 months
- Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score \> 7, serum PSA \> 20 µg/L, OR minimum clinical T-stage T2c.
Exclusion
- Unable to obtain consent
- Weight \>225 kg (weight limitation of PET/CT scanner)
- Unable to lie flat for 30 minutes to complete the PET-CT imaging session
- Lack of intravenous access
- Both CT scan of the chest, abdomen, and pelvis and 99mTc-MDP bone scan within 3 months
- History of allergic reaction to 18F-PSMA-1007 or 99mTc-MDP
Key Trial Info
Start Date :
August 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04733768
Start Date
August 31 2021
End Date
August 9 2022
Last Update
September 19 2024
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7