18F-PSMA-1007 PET/CT Imaging in Patients With Biochemically Recurrent or High-risk Prostate Cancer

Study Overview
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Brief Summary
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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
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A single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in specific patient populations: 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 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. 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

Official Title
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18F-PSMA-1007 PET/CT Imaging in Patients With Biochemically Recurrent or High-risk Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: 18F-PSMA-1007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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: Unable to obtain consent Weight >225 kg (weight limitation of PET/CT scanner) Unable to lie flat for 30 minutes to complete the PET-CT imaging session Lack of intravenous access Both CT scan of the chest, abdomen, and pelvis and 99mTc-MDP bone scan within 3 months History of allergic reaction to 18F-PSMA-1007 or 99mTc-MDP

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-PSMA-1007 PET/CT scan<br>Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan | Diagnostic Test: 18F-PSMA-1007<br>* 18f-PSMA-1007 PET/CT scan<br>* Other names: [18F]PSMA-1007;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - immediate | Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site | Immediately (within 15 minutes) after 18F-PSMA-1007 injection | 
| Safety - post scan | Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site | 2.5 hours after 18F-PSMA-1007 injection | 
| Safety - delayed | Questionnaire (open-ended) to referring physicians to document any perceived delayed adverse events related to 18F-PSMA-1007 tracer injection | 6 months after 18F-PSMA-1007 injection | 
| Biodistribution | Evaluation of whether tracer distribution is as expected based on published normal distribution and known disease | Within 5 days of scan | 
| Diagnostic Accuracy | 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. | 1 year after 18F-PSMA-1007 PET/CT scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Efficacy | Questionnaire completed by referring physicians evaluating the perceived clinical effect of the 18F-PSMA-1007 PET/CT on patient management | 6 months after the 18F-PSMA-1007 PET/CT scan |