PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer
PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer
The standard of care imaging of prostate cancer metastases recommended by the National
 Comprehensive Cancer Network (NCCN), CT of the chest/abdomen/pelvis and bone scan, may be
 suboptimal. PyL is a novel PET tracer designed to detect prostate specific membrane antigen
 (PSMA) expressed on prostate cancer cells. PyL PET/CT may provide improved evaluation of
 clinically significant metastases in patients with prostate cancer.
This will be a phase II clinical trial to assess the clinical value of PyL for detection of
 disease in pateints with:

 1. High risk prostate cancer and planned prostatectomy or radiation therapy (arm 1) and

 2. Biochemically recurrent prostate cancer (arm 2) but without evidence of disease of
 standard of care imaging (CT of the chest/abdomen/pelvis and bone scan).

 In both cohorts, PyL PET/CT will be obtained and evaluated by a nuclear radiologist trained
 in novel PET radiotracers, including PyL. Lesions suspicious for disease of PyL that were
 unsuspected on standard of care imaging will be selected for biopsy for pathologic
 confirmation if feasible . Pathology will be used as the reference standard for confirming
 malignancy.
Inclusion Criteria:

 1. Male ≥ 18 years of age.

 2. Histologically confirmed adenocarcinoma of the prostate

 3. Patients meet one of the follow criteria:

 Cohort 1: High risk prostate cancer (PSA >10, Gleason 8-10, or clinical stage >T2c) and
 planned prostatectomy or radiation therapy or Cohort 2: Biochemical prostate cancer relapse
 (Prostate Specific Antigen (PSA) > 0.2 ng/ml in patients following prostatectomy or ≥ 2
 ng/ml more than the PSA nadir in patient following radiotherapy, as defined by the
 ASTRO-Phoenix criteria [18] and no evidence of malignancy on standard of care imaging for
 metastases (CT of the chest/abdomen/pelvis and bone scan) within 3 months.

 Exclusion Criteria:

 1. Presence of a condition or abnormality that in the opinion of the Investigator would
 compromise the safety of the patient or the quality of the data.

 2. Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners
 may not be able to function with patients over 450 pounds.

 3. Change in therapy since standard of care imaging