Prostate Cancer
Conditions
Keywords
PSMA, Recurrent prostate cancer, Diagnostic accuracy, 18F-PSMA-1007, [18F]PSMA-1007
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TEST[18F]PSMA-1007
PSMA PET/CT using the intervention.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult Patients referred for investigation of recurrent PC by PSMA PET/CT. * Patients with known biochemical recurrence of a histologically confirmed primary prostate cancer, defined as: Post prostatectomy: two consecutive PSA \> 0.2 ng/ml Post-radiotherapy: a rise of 2ng/mL \> post-therapy nadir (ASTRO consensus definition) * Male patients \>18 years old * PSA measured ± 4 weeks of the PSMA-PET/CT * Patients willing and able to consent to the informed consent document
Exclusion criteria
* Patients with ADT within 6 months prior to the PSMA-PET/CT * Inability to provide informed, written consent * Patients undergoing active treatment for a second non-prostatic malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary objective: To confirm the PPV of the new tracer (patient-based PPV) | At one year follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer | Within one week of scan | Patient based detection (PET-positivity) rate (stratified by PSA value) |
| To explore the regional based PPV | At one year follow up | Region-based PPV (prostate bed, pelvic lymph nodes, extra-pelvic lymph nodes, extra-pelvic viscera and bone metastases) |
Other
| Measure | Time frame | Description |
|---|---|---|
| To calculate the inter-reader reliability | Within one month of scan | 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. |
| Frequency of diagnostic pitfalls or indeterminate lesions requiring follow-up | Within one month of scan | The frequency of indeterminate lesions requiring follow up / indeterminate lesions will be recorded by all readers and analysed by descriptive statistics |
| Number of patients with adverse events. | Up to 48 hours follow up post scan | 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. |
Countries
Switzerland
Outcome results
None listed