Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging

Biochemical recurrent (i. Inclusion/Exclusion) and preprostatectomy (ii. Inclusion/Exclusion) staging patients will be eligible for the expanded access protocol. In order to be eligible to participate in this study, an individual must meet the following criteria:

Biochemical Recurrence Population:

i. Inclusion Criteria:

• Histopathological proven prostate adenocarcinoma.

• Rising prostatic specific antigen(PSA) after definitive therapy with prostatectomy or radiation therapy.

  • Post radical prostatectomy (RP)
  • PSA equals to or greater than 0.2 ng/mL measured more than 6weeks after RP
  • Post-radiation therapy -ASTRO-Phoenix consensus definition
  • Nadir + greater than or equal to 2 ng/mL rise in PSA
• Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/ World Health Organization (WHO) equivalent).
• Age > 18.

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

  i. Exclusion Criteria:

• Concomitant investigational therapy.
• Known inability to lie flat, remain still or tolerate a PET scan.
• Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Preprostatectomy Staging Population:

ii. Inclusion criteria:

• Biopsy proven prostate adenocarcinoma.
• Considered for prostatectomy with lymph node dissection.
• Intermediate to high-risk disease (as determined by elevated PSA [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors).
• Able to provide written consent.
• Karnofsky performance status of ≥50 (or ECOG/WHO equivalent).

ii. Exclusion criteria:

• Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
• Neoadjuvant chemotherapy, radiation therapy or any definitive local therapy prior to prostatectomy including focal ablation techniques (HiFu).