University of Alberta
25/07/2023
01/12/2028
MEN
2800
18
No
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 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
18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
- 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)
- 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
| PARTICIPANT GROUP ARM | INTERVENTION TREATMENT |
|---|---|
| xperimental: 18F-PSMA-1007 18F-PSMA-1007, 4 MBq/kg (max 400 MBq; +/- 15%), intravenous, single dose | Drug: 18F-PSMA-1007 18F-PSMA-1007 intravenous injection |
| Measures | Measure Description | MEASURE 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 |