18f-psma-1007 pet/ct imaging in patients with biochemically recurrent or high-risk prostate cancer

Conditions: Prostate Cancer

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).

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

Eligibility criteria:
inclusion criteria: 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. exclusion criteria: 1. unable to obtain consent 2. weight \>225 kg (weight limitation of pet/ct scanner) 3. unable to lie flat for 30 minutes to complete the pet-ct imaging session 4. lack of intravenous access 5. both ct scan of the chest, abdomen, and pelvis and 99mtc-mdp bone scan within 3 months 6. history of allergic reaction to 18f-psma-1007 or 99mtc-mdp