Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489496
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-21
Brief Title:
Prostate Cancer 18F-PSMA-1007 PETCT Access Trial
Sponsor:
Alberta Health services
Organization:
Alberta Health services
Study Overview
Official Title:
Prostate Cancer 18F-PSMA-1007 PETCT Access Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAX
Brief Summary:
Primary objective
To determine if 18F-PSMA-1007 PETCT imaging is effective at diagnosing prostate cancers andor 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 PETCT imaging is available
To determine if 18F-PSMA-1007 PETCT imaging is effective at diagnosing prostate cancers andor 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 PETCT 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 PETCT 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 PETCT Imaging will be conducted beginning 90-120 minutes after an injection of 4 MBqkg max 400 MBq - 15 18F-PSMA-1007 in patients
After the 18F-PSMA-1007 PETCT 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 PETCT will be compared to any prior imaging and pathologic results
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 PETCT 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 PETCT Imaging will be conducted beginning 90-120 minutes after an injection of 4 MBqkg max 400 MBq - 15 18F-PSMA-1007 in patients
After the 18F-PSMA-1007 PETCT 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 PETCT will be compared to any prior imaging and pathologic results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None