Clinical trial NCT04986280: Diagnostic Accuracy and Performance of 18F-PSMA-1007
Official title: Diagnostic Accuracy and Performance of 18F-PSMA-1007 in the Detection of Recurrent Prostate Cancer - a Prospective, Single-arm Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: PSMA
Recurrent prostate cancer
Diagnostic accuracy
18F-PSMA-1007
[18F]PSMA-1007
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 174
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary objective: To confirm the PPV of the new tracer (patient-based PPV)
timeFrame: At one year follow up
Secondary outcomes:
measure: • To determine the patient-based detection rate of pathologic scans (sensitivity) for the new tracer
timeFrame: Within one week of scan
measure: To explore the regional based PPV
timeFrame: At one year follow up
Other outcomes:
measure: To calculate the inter-reader reliability
timeFrame: Within one month of scan
measure: Frequency of diagnostic pitfalls or indeterminate lesions requiring follow-up
timeFrame: Within one month of scan
measure: Number of patients with adverse events.
timeFrame: Up to 48 hours follow up post scan
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
Study officials:
affiliation: Deputy Clinic Director
name: Ali Afshar-Oromieh, MD
role: STUDY_CHAIR
References: