Status:
NOT_YET_RECRUITING
Prostate Cancer 18F-PSMA-1007 PET/CT Access Trial
Lead Sponsor:
Alberta Health services
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
Primary objective: • To determine if 18F-PSMA-1007 PET/CT imaging is effective at diagnosing prostate cancers and/or metastases compared to conventional imaging \[including CT, MRI, 99mTc-MDP Bone Sc...
Detailed Description
Prostate Cancer is the most frequent cancer in men worldwide and accounts for the second leading cause of cancer-related death in men in the United States. Local tumor invasion into neighboring organs...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years.
- Able and willing to follow instructions and comply with the protocol.
- Provide written informed consent prior to participation in the study.
- One of the following:
- a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 µg/L
- 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
- 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 ≥ 8, serum PSA \> 20 µg/L, OR minimum clinical T-stage T3a
- 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
- Unable to obtain consent
- Age less than 18 years.
- Unable to lie flat for 30 minutes to compete PET/CT imaging.
- Lack of intravenous access
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06489496
Start Date
October 1 2024
End Date
October 1 2030
Last Update
July 8 2024
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