Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)

Inclusion Criteria:

* Signed informed consent;
* ≥18 years of age;
* Life expectancy \>3 months;
* Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy;
* Have ≥1 of the following intermediate- to high-risk features:

  1. PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment;
  2. International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above;
  3. Clinical stage greater than or equal to T2b;
* Participants must have adequate renal function;
* Sexually active participants who have female partners of childbearing potential: Partner and/or participant must agree to use an acceptable form of contraception. Further participants must refrain from donating sperm;
* A 68Ga-PSMA-11 PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SAR-bisPSMA.

Exclusion Criteria:

* Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy;
* Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11);
* Known hypersensitivity to the components of 64Cu-SAR-bisPSMA;
* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;
* Any serious medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;
* Patients unwilling or unable to comply with protocol or with a history of noncompliance or inability to grant informed consent.