Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Whereas 18F-PSMA-1007 has rapidly established itself as a radiotracer for the investigation of prostate cancer, there are no studies confirming its diagnostic performance. The purpose of this study is to determine the diagnostic performance for this radiotracer.
In this prospective, single-armed diagnostic imaging study men undergoing standard-of-care PSMA PET/CT using [18F]PSMA-1007 shall be studied. The primary objective is to confirm the positive predictive value (PPV) of this tracer at a patient-based level by recruiting until 53 patients with follow-up to a composite reference standard are available. Secondary outcomes shall include patient based rate of pathological-scans stratified by PSA, the PPV stratified by region , interrelate agreement, frequency of indeterminate lesions and the safety and tolerability of the examination.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Arm 1 - All patients will undergo PET/CT with 18F-PSMA-1007 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]PSMA-1007 | Diagnostic Test | PSMA PET/CT using the intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary objective: To confirm the PPV of the new tracer (patient-based PPV) | The primary end point is the per patient PPV for the detection of PSMA-positive tumour lesions as confirmed by either a) histology or b) a composite reference standard of imaging and/or PSA fall following focal therapy in the absence of systemic therapy. | At one year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| • To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer | Patient based detection (PET-positivity) rate (stratified by PSA value) | Within one week of scan |
| To explore the regional based PPV |
| Measure | Description | Time Frame |
|---|---|---|
| To calculate the inter-reader reliability | The interrater agreement (ordinal scale, no units) for PET-findings will be determined. The joint-interrate reliability will be compared by a combined assessment of Fleiss' kappa and Krippendorf's alpha. | Within one month of scan |
| Frequency of diagnostic pitfalls or indeterminate lesions requiring follow-up |
Inclusion Criteria:
Post prostatectomy: two consecutive PSA > 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL > post-therapy nadir (ASTRO consensus definition)
Exclusion Criteria:
Not provided
Not provided
Not provided
The data will be obtained prospectively from patients referred for routine 18F-PSMA-11 PET/CT for recurrent prostate cancer at the university clinic for nuclear medicine, Inselspital Bern. Follow up data (further imaging, laboratory parameters and details of further treatment) will be collected up to 12 months' follow up from the date of examination.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ali Afshar-Oromieh, MD | Deputy Clinic Director | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital, Universitätsspital Bern | Bern | 3010 | Switzerland |
Upon reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Region-based PPV (prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, extra-pelvic viscera and bone metastases)
| At one year follow up |
The frequency of indeterminate lesions requiring follow up / indeterminate lesions will be recorded by all readers and analysed by descriptive statistics |
| Within one month of scan |
| Number of patients with adverse events. | Patients will be contacted by phone one to three days post imaging and assessed for adverse events (AE). Any reported events will be followed up by a physician in the clinic for study related adverse events requiring further evaluation. Adverse events are as defined in supplementary materials and will be recorded using the AE form in the eCRF. | Up to 48 hours follow up post scan |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |