Actively Recruiting
18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Phase III Access Trial 2022 to 2028
Led by University of Alberta · Updated on 2025-09-23
2800
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 18F-PSMA-1007 PET/CT imaging in adult men with prostate cancer, particularly those with a history of radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy, or who have high-risk features for metastatic disease. This phase III study aims to assess the safety of the 18F-PSMA-1007 tracer and to analyze non-specific bone lesions detected during imaging. Participants include men aged 18 and older with specific PSA levels or clinical features related to prostate cancer. Participants will receive a single intravenous injection of 18F-PSMA-1007 at a dose of 4 MBq/kg (up to a maximum of 400 MBq). The study involves imaging with PET/CT following tracer injection to observe the distribution and activity of the tracer. The safety of the tracer will be monitored immediately after injection, after the scan (approximately 2.5 hours later), and for delayed adverse events up to 7 days post-injection. Researchers will also follow non-specific bone lesions identified during the scan for at least one year to determine their nature. During the study, participants will be screened for adverse effects at multiple time points, including immediately post-injection and post-scan. They will receive information to self-report any delayed side effects occurring within one week after injection. The study will record and evaluate up to five non-specific bone lesions per participant, tracking their size and location. Safety assessments continue for up to a year after the scan to better understand the clinical relevance of these lesions. Participation duration varies depending on follow-up assessments.
CONDITIONS
Brief Title
18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males aged 18 years or older
- History of radical prostatectomy for prostate cancer with a PSA level of 0.2 mcg/L or higher
- History of radiotherapy, cryotherapy, or brachytherapy for prostate cancer with a rising PSA level of 2 mcg/L or higher (minimum two samples) or a PSA doubling time less than 9 months
- History of biopsy-proven prostate cancer with high-risk features prior to treatment, including Gleason score 7 or higher, PSA 20 mcg/L or higher, or clinical T-stage T2c or above
- Patients who do not meet above criteria but in whom the 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a qualified physician licensed in Alberta
You will not qualify if you...
- Unable to provide consent
- Weight over 225 kg
- Unable to lie flat for 30 minutes to complete PET/CT imaging
- Lack of intravenous access
- History of allergic reaction to 18F-PSMA-1007
- Residence outside Alberta, Northwest Territory, or Yukon Territory (Canada)
- Under 18 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Duration - Single day
Participants receive a single intravenous injection of 18F-PSMA-1007 followed by PET/CT imaging to assess prostate cancer.
1 visit (in-person) for injection and imaging
Duration - Up to 1 year
Participants are monitored for safety and assessment of non-specific bone lesions up to 1 year after the tracer injection.
1 visit at 2.5 hours post-injection, 1 visit between 1-7 days post-injection, and 1 visit at 1 year post-injection
Trial Site Locations
Total: 1 location
1
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Actively Recruiting
Research Team
J
Jonathan T Abele, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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