Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-29 @ 4:24 AM
Study NCT ID:
NCT04733768
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-PSMA-1007 PET/CT Imaging in Patients with Biochemically Recurrent or High-risk Prostate Cancer
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
18F-PSMA-1007 PET/CT Imaging in Patients with Biochemically Recurrent or High-risk Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2024-09
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:
None
Brief Summary:
Single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in patients with biochemically recurrent or high-risk prostate cancer. Safety, biodistribution, clinical efficacy, and diagnostic accuracy will be assessed. For diagnostic accuracy comparison will be made to a contemporary (within 10 days) conventional imaging study (bone scan and CT scan).
Detailed Description:
A single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in specific patient populations:
1. Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) \> 0.2 µg/L
2. Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of \< 9 months
3. Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score \> 7, serum PSA \> 20 µg/L, OR minimum clinical T-stage T2c.
All patients will have a comparison conventional imaging study performed within 10 days of the investigational PET/CT scan. The conventional imaging study will include a 99mTc -MDP bone scan including whole body planar imaging (top of skull to toes) as well as SPECT/CT imaging of the trunk (including clavicles to pelvis). In the absence of contraindications (renal failure with eGFR \< 40 mL/min/1.73m2 or history of IV contrast allergy), all scans will include an IV-contrast enhanced CT scan of the chest, abdomen, and pelvis. In the presence of contraindications to IV contrast, a non-IV contrast enhanced CT scan of the chest, abdomen, and pelvis will be performed.
The biodistribution of 18F-PSMA-1007 produced by the Edmonton PET Centre will be evaluated in 2 ways:
* by comparing the biodistribution of tracer on the scans to an expected normal distribution.
* for any identified abnormal distribution, a lesion-by-lesion comparison to the conventional imaging study will be performed with lesions classified as follows:
* A - lesion identified on the investigational imaging study but not on the conventional imaging study
* B - matching lesions on both the investigational and conventional imaging studies
* C - lesion identified on the conventional imaging study but not on the investigational imaging study
The clinical efficacy of 18F-PSMA-1007 will be evaluated as follows:
• a follow-up questionnaire will be sent to referring clinicians 6 months after the scan to determine if the scans were of perceived clinical benefit.
The safety of 18F-PSMA-1007 produced by Edmonton PET Centre will be evaluated in 3 ways:
* the patients will be screened for adverse effects immediately post-injection as well as after the scan (approximately 2.5 hours after injection)
* the patients will be provided an information sheet and contact information for self-reporting of delayed adverse events (1-7 days post injection)
* a 6 month follow-up questionnaire will be sent to referring clinicians to determine if there were any perceived adverse events related to the injection
The diagnostic accuracy of 18F-PSMA-1007PET/CT produced by Edmonton PET Centre will be evaluated as follows:
* All lesions categorized as "A", "B", or "C" will be compared with a reference standard to determine sensitivity and specificity on both a per lesion and per patient level
* The reference standard will be defined a minimum of 1 year after completion of both scans based on available clinical data
* Lesional histopathology results will be used as the reference standard when available
* When pathology is unavailable, criteria for determining lesional positivity for metastatic disease will be based on recently published methodology (Lawhn-Heath et al., AJR 2019;213:1-8)
* If lesion the criteria for determining lesion positivity are not met, the lesion will be considered unevaluable and will be excluded from assessment of accuracy
1. Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) \> 0.2 µg/L
2. Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of \< 9 months
3. Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score \> 7, serum PSA \> 20 µg/L, OR minimum clinical T-stage T2c.
All patients will have a comparison conventional imaging study performed within 10 days of the investigational PET/CT scan. The conventional imaging study will include a 99mTc -MDP bone scan including whole body planar imaging (top of skull to toes) as well as SPECT/CT imaging of the trunk (including clavicles to pelvis). In the absence of contraindications (renal failure with eGFR \< 40 mL/min/1.73m2 or history of IV contrast allergy), all scans will include an IV-contrast enhanced CT scan of the chest, abdomen, and pelvis. In the presence of contraindications to IV contrast, a non-IV contrast enhanced CT scan of the chest, abdomen, and pelvis will be performed.
The biodistribution of 18F-PSMA-1007 produced by the Edmonton PET Centre will be evaluated in 2 ways:
* by comparing the biodistribution of tracer on the scans to an expected normal distribution.
* for any identified abnormal distribution, a lesion-by-lesion comparison to the conventional imaging study will be performed with lesions classified as follows:
* A - lesion identified on the investigational imaging study but not on the conventional imaging study
* B - matching lesions on both the investigational and conventional imaging studies
* C - lesion identified on the conventional imaging study but not on the investigational imaging study
The clinical efficacy of 18F-PSMA-1007 will be evaluated as follows:
• a follow-up questionnaire will be sent to referring clinicians 6 months after the scan to determine if the scans were of perceived clinical benefit.
The safety of 18F-PSMA-1007 produced by Edmonton PET Centre will be evaluated in 3 ways:
* the patients will be screened for adverse effects immediately post-injection as well as after the scan (approximately 2.5 hours after injection)
* the patients will be provided an information sheet and contact information for self-reporting of delayed adverse events (1-7 days post injection)
* a 6 month follow-up questionnaire will be sent to referring clinicians to determine if there were any perceived adverse events related to the injection
The diagnostic accuracy of 18F-PSMA-1007PET/CT produced by Edmonton PET Centre will be evaluated as follows:
* All lesions categorized as "A", "B", or "C" will be compared with a reference standard to determine sensitivity and specificity on both a per lesion and per patient level
* The reference standard will be defined a minimum of 1 year after completion of both scans based on available clinical data
* Lesional histopathology results will be used as the reference standard when available
* When pathology is unavailable, criteria for determining lesional positivity for metastatic disease will be based on recently published methodology (Lawhn-Heath et al., AJR 2019;213:1-8)
* If lesion the criteria for determining lesion positivity are not met, the lesion will be considered unevaluable and will be excluded from assessment of accuracy
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: