18F-PSMA-1007 PET/CT Imaging in Patients With Biochemically Recurrent or High-risk Prostate Cancer
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
A single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in specific patient populations:
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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
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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
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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:
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by comparing the biodistribution of tracer on the scans to an expected normal distribution.
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for any identified abnormal distribution, a lesion-by-lesion comparison to the conventional imaging study will be performed with lesions classified as follows:
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A - lesion identified on the investigational imaging study but not on the conventional imaging study
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B - matching lesions on both the investigational and conventional imaging studies
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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:
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the patients will be screened for adverse effects immediately post-injection as well as after the scan (approximately 2.5 hours after injection)
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the patients will be provided an information sheet and contact information for self-reporting of delayed adverse events (1-7 days post injection)
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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:
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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
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The reference standard will be defined a minimum of 1 year after completion of both scans based on available clinical data
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Lesional histopathology results will be used as the reference standard when available
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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)
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 18F-PSMA-1007 PET/CT scan Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan |
Diagnostic Test: 18F-PSMA-1007
18f-PSMA-1007 PET/CT scan
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety - immediate [Immediately (within 15 minutes) after 18F-PSMA-1007 injection]
Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site
- Safety - post scan [2.5 hours after 18F-PSMA-1007 injection]
Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site
- Safety - delayed [6 months after 18F-PSMA-1007 injection]
Questionnaire (open-ended) to referring physicians to document any perceived delayed adverse events related to 18F-PSMA-1007 tracer injection
- Biodistribution [Within 5 days of scan]
Evaluation of whether tracer distribution is as expected based on published normal distribution and known disease
- Diagnostic Accuracy [1 year after 18F-PSMA-1007 PET/CT scan]
Lesion by lesion comparison to conventional imaging (bone scan and CT scan) performed 2-10 days after the 18F-PSMA-1007 PET/CT scan. Reference standard based on lesion pathology (if available) or 1 year clinical/imaging following (using criteria published by Lawhn-Heath et al., AJR 2019;213:1-8.
Secondary Outcome Measures
- Clinical Efficacy [6 months after the 18F-PSMA-1007 PET/CT scan]
Questionnaire completed by referring physicians evaluating the perceived clinical effect of the 18F-PSMA-1007 PET/CT on patient management
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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
-
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.
Exclusion Criteria:
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Unable to obtain consent
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Weight >225 kg (weight limitation of PET/CT scanner)
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Unable to lie flat for 30 minutes to complete the PET-CT imaging session
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Lack of intravenous access
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Both CT scan of the chest, abdomen, and pelvis and 99mTc-MDP bone scan within 3 months
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History of allergic reaction to 18F-PSMA-1007 or 99mTc-MDP
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alberta | Edmonton | Alberta | Canada | T6G 2B7 |
Sponsors and Collaborators
- University of Alberta
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CC-20-0281