Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer

Inclusion Criteria:

1. The patient (male) is aged 18 years or above.

2. The patient is able to understand the information presented to him concerning thenature, scope, and consequences of the trial as set out in the information providedto the patient AND has provided written informed consent to participate.

3. The patient has newly diagnosed, biopsy-proven, clinically localized prostateadenocarcinoma, and curative prostatectomy with extended pelvic lymph nodedissection is his preferred course of treatment.

4. The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following:

• Overall ISUP grade group 4 or 5,

• Clinical category T3a or greater,

• Serum PSA level greater than 20 ng/ml.

5. The patient has undergone conventional imaging (CT or MRI, and bone scan ifclinically indicated) to detect the presence of pelvic nodal involvement and bone orvisceral metastases within 60 days of the planned PET-CT procedure.

Exclusion Criteria:

1. Patients for whom radical prostatectomy is not clinically appropriate or the patientis otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymphnode dissection.

2. The patient has received any therapy - be it radiation, surgical or drug therapy -for his prostate cancer.

3. The patient has any contraindication(s) for and/or known hypersensitivity to anyconstituent(s) of [18F]PSMA-1007.

4. The patient is not able to have PET-CT scans (for example, because of weight,claustrophobia, or inability to lie still for the duration of the scan).

5. The patient is closely affiliated to the investigation site; e.g. is a first-degreerelative of the investigator.

6. At the time of screening, the patient is receiving any other investigationalagent(s), or he has received any such agent(s) within the previous 30 days, or he isscheduled to receive any such agent(s) in the period up to the planned date for thelast study visit.

7. The patient has previously been enrolled in this trial.

8. The patient has previously undergone PET imaging with any PSMA-avid product.

9. The patient has histological evidence of small-cell carcinoma of the prostate.

10. The patient is clinically unstable or requires emergency treatment.

11. The patient has any mental condition rendering him incapable of understanding thenature, scope, and consequences of the trial as set out in the information given tothe patient.