Prostate Cancer 18F-PSMA-1007 PET/CT Access Trial
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorAlberta Health services
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 µg/L
Disqualifiers
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
Trial population
Male patients with history of prostate cancer for staging or clinically suspected recurrent prostate cancer
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
18F-1007 PSMA PSMA PET/CT
Diagnostic testEach 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: