NCT06489496

Prostate Cancer 18F-PSMA-1007 PET/CT Access Trial

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Alberta Health services · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[including CT, MRI, 99mTc-MDP Bone Scans as available\]. Secondary Objective: * To determine safety by evaluating for adverse events * To determine which conventional imaging is being performed when 18F-PSMA-1007 PET/CT imaging is available

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 such as the seminal vesicle and bladder with distant metastasis to pelvic lymph nodes and bones are frequent. Determining if tumor spread is local or distant influences therapy decisions. Conventional imaging with CT, MRI and bone scans have been used for staging and diagnosis; however, assessment of metastasis particularly lymph node and bone metastasis has remained unsatisfactory. New imaging approaches, which accurately assess disease, are needed to achieve optimal treatment and improve patient outcomes . In general, PSMA PET imaging appears to have a diagnostic benefit in patients with biochemically recurrent prostate cancer based on elevated serum prostate specific antigen (PSA) levels and negative conventional imaging such as CT and 99mTc-MDP bone scan. It also appears that PSMA PET may perform better over conventional imaging in the initial staging of patients with high-risk prostate cancer. Comparisons between PSMA PET and conventional imaging have been favorable; however, most of these studies have looked at radiopharmaceuticals 18F-DCFPyL or 68Ga-PSMA-11. Studies performed to date have shown that 18F-PSMA-1007 is like other PSMA radiopharmaceuticals in detecting tumor sites. One systematic review demonstrated 18F-PSMA-1007 changed management in 20% of patients at staging. The expectation is that 18F-PSMA-1007 may also eventually replace conventional imaging in the staging and biochemical recurrence work up as other PSMA PET agents. However, larger prospective studies are needed to strengthen its role. 18F-PSMA-1007 PET/CT imaging is changing the management of prostate cancer and may eventually replace conventional imaging in staging and work up for biochemical recurrence. The purpose of this study is to determine if it can replace current conventional imaging (such as CT, MRI, 99mTc-MDP Bone Scans) in clinical practice. The study will also provide patients in Southern Alberta access to this exam that will help with their patient care management. '• Prospective Phase 3 trial * Each patient will receive an IV injection 18F-PSMA-1007 PET/CT. Imaging will be conducted beginning 90-120 minutes after an injection of 4 MBq/kg (max 400 MBq +/- 15%) 18F-PSMA-1007 in patients. * After the 18F-PSMA-1007 PET/CT acquisition is complete, a CT scan will be performed for attenuation correction and localization in the same in line gantry without patient movement between the two scans. * The results of the 18F-PSMA-1007 PET/CT will be compared to any prior imaging and pathologic results.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F-1007 PSMA PSMA PET/CT	Each patient will receive an IV injection 18F-PSMA-1007 PET/CT. PET/CT Imaging will be conducted beginning 90-120 minutes after an injection of 4 MBq/kg (max 400 MBq +/- 15%) 18F-PSMA-1007 in patients.

Timeline

• Start date: 2024-10-01
• Primary completion: 2029-10-01
• Completion: 2030-10-01
• First posted: 2024-07-08
• Last updated: 2024-07-08