Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

This study evaluates Gallium-68 labelled PSMA-11 (also called Gallium-68 labelled
PSMA-HBED-CC, or Gallium-68 labelled PSMA
N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid), abbreviated here as 68Ga-PSMA.
This molecule (or radiotracer) binds to receptors that are often present on prostate cancer
cells. Using 68Ga-PSMA together with a positron emission tomography (PET) scanner (with
computed tomography, called PET/CT), it is therefore possible to find prostate cancer lesions
in the body. The study will test whether 68Ga-PSMA will identify prostate cancer more
precisely than normal imaging methods (for example CT, MRI, or bone scan). A more precise
identification of the location of the disease is important. Knowing where the disease is
located will help to decide on the best course of action to treat the disease.

Men who have elevated tumor markers of prostate cancer are eligible for this study.
Participants undergo a 68Ga-PSMA PET/CT scan before further treatment. Based on clinical
information, including any prior imaging and biopsy/surgery information and follow-up
information, we will determine whether 68Ga-PSMA PET/CT imaging was more accurate than the
standard imaging. The study team will collect this information for up to 1 year after the
68Ga-PSMA PET/CT scan.

The results of the 68Ga-PSMA PET/CT scan will be shared with the participating patients.
Also, results will be entered into the participant's medical record and shared with the
treating physicians.

Inclusion Criteria:

1. Histopathological proven prostate adenocarcinoma.

2. Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or
radiation therapy (external beam or brachytherapy).

1. Post radical prostatectomy (RP) - according to American Urological Association
(AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6
weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.

2. Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir +
greater than or equal to 2 ng/mL rise in PSA.

3. Karnofsky performance status of ≥ 50.

4. Age ≥ 18.

5. Ability to understand a written informed consent document, and the willingness to sign
it.

Exclusion Criteria:

1. Current investigational therapy for prostate cancer.

2. Unable to lie flat, still or tolerate a PET/CT scan.

3. Prior history of a malignancy within the last 2 years, except skin basal cell or
cutaneous superficial squamous cell carcinoma that has not metastasized, and except
superficial bladder cancer.

4. Prisoner.