For males ages 18 years and up
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:
- 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.
- 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).
