18F-PSMA-1007 PET/CT Imaging in Patients With Biochemically Recurrent or High-risk Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: 18F-PSMA-1007
- Registration Number
- NCT04733768
- Lead Sponsor
- University of Alberta
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 100
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-PSMA-1007 PET/CT scan 18F-PSMA-1007 Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan
- Primary Outcome Measures
Name Time Method 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
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
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
Name Time Method 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
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada