18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028

Study Overview
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Brief Summary
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A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations: Adults patients (≥18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L Adult patients with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months Adult patients 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 mcg/L, OR minimum clinical T-stage T2c Adult patients who do not meet criteria 1-3 but in whom a 18F-PDAM-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta) The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways: The participant will be screened for adverse effects immediately post-injection The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection) The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-7 days post injection) The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows: All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax > 2.5 but no corresponding lesion on CT) will be recorded The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant) Recorded lesions will be evaluated a minimum of 1 year post-scan to determine whether they are benign or malignant based on previously published reference standard criteria (Arnfield et al., 2021) Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy

Official Title
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18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 18F-PSMA-1007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L Adult participants with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months Adult participants with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, brachytherapy, or other similar therapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c Adult patients who do not meet criteria 1-3 but in whom a 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta) Exclusion Criteria: Unable to obtain consent Weight > 225 kg (weight limit of PET/CT scanners) Unable to lie flat for 30 minutes to complete the PET/CT imaging session Lack of intravenous access History of allergic reaction to 18F-PSMA-1007 Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada) Less than 18 years old NOTE: Androgen deprivation therapy (ADT) is NOT a contraindication to participation

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
Interventional Model Description: Two-centre prospective cohort phase III study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-PSMA-1007<br>18F-PSMA-1007, 4 MBq/kg (max 400 MBq; +/- 15%), intravenous, single dose | Drug: 18F-PSMA-1007<br>* 18F-PSMA-1007 intravenous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - immediate | The participant will be screened for adverse effects immediately post-injection | Immediately after tracer injection | 
| Safety - post scan | The participant will be screened for adverse effects immediately after the scan (approx 2.5 hours after injection). | 2.5 hours after tracer injection | 
| Safety - delayed | The participant will be provided information to contact the study team to self-report and delayed adverse events (1-7 days post-injection) | 1-7 days after tracer injection | 
| Non-specific bone lesion assessment (NSBLs) | SUVmax and anatomic location of NSBLs (max 5 per participant) will be compared to a reference standard 1 year after tracer injection | 1 year after tracer injection |