An observational study in Prostate Cancer, sponsored by Alberta Health services. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Alberta Health services · Observational
Primary objective:
Secondary Objective:
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
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Alberta Health services is the lead sponsor of 40 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male patients with history of prostate cancer for staging or clinically suspected recurrent prostate cancer
One of the following:
Exclusion Criteria:
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.
Comparison of 18F-PSMA-1007 PET/CT imaging to CT/MRI/Bone scans in identifying prostate cancer and/or metastases
calculate sensitivity and specificity 18F-PSMA 1007 PET/CT compared to CT, MRI and bone scans using pathology and follow up as gold standard.
Time frame: 5 year study, approximately 200 patients/ year.
To determine safety by evaluating for adverse events
evaluate patient reported side effects during and after injection of 18F-PSMA 1007 while in the department
Time frame: 5 year study, approximately 200 patients/ year.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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