18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

Summary

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Description

Background Prostate cancer (PCa) is the second leading cause of cancer death in American men. Patients with high risk but apparently localized disease are often understaged because disease beyond the prostate is not well detected and thus leads to overtreatment with prostatectomy Recurrence of PCa a...

Background Prostate cancer (PCa) is the second leading cause of cancer death in American men. Patients with high risk but apparently localized disease are often understaged because disease beyond the prostate is not well detected and thus leads to overtreatment with prostatectomy Recurrence of PCa after surgery or radiation is very common and sometimes progresses to death. Early intervention for recurrence has been shown to be of benefit but current methods of localizing recurrence are either insensitive (CT), non-specific (MRI) or both (bone scan) Many prostate cancers express the prostate specific membrane antigen (PSMA) a transmembrane protein with NAALADase (N-acetylated-alphalinked- acidic dipeptidase) and folate hydrolase enzymatic activity. PSMA is also expressed in angiogenesis but otherwise has limited expression in normal tissue. An initial test of (18)F-DCFBC, a first-generation PET agent targeting PSMA, in patients with advanced local disease and biochemically recurrent prostate cancer demonstrated the potential of PET to detect sites of recurrence but it was hampered by excessive blood pool activity. (18)F-DCFPyL, a second generation PSMA PET agent, binds with high affinity to PSMA yet clears rapidly from the blood pool and thus, whole-body PET imaging with this agent, may provide a new tool in staging high risk cancers and detecting recurrent disease. Primary Objective - To assess the ability of (18)F-DCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer. Eligibility Age greater than or equal to 18 years old ECOG 0-2 Histologically confirmed adenocarcinoma of the prostate Patients fit criteria for one of the following categories: Cohort 1: known localized high risk prostate cancer (PSA >10, Gleason 8-10 or clinical stage greater than or equal to T2c) with evidence of disease on standard imaging, or Cohort 2: nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/ml Design This is a single site study enrolling a total of 330 patients Up to 50 evaluable patients with presumed localized high-risk prostate cancerscheduled to undergo prostatectomy or biopsy within 4 months of enrollment. 250 evaluable patients with suspected recurrent prostate cancer without definitive evidence of disease on conventional imaging will be enrolled. Up to 5 eligible patients in cohort 2 will receive a second 18F-DCFPyL PET/CT scan within 1 month of the first study immediately after unilateral salivary gland cannulation and an infusion of unlabeled DCFPyL into the cannulated gland. To account for the non-evaluable patients the accrual ceiling will be set to 330. All patients will undergo a standard of care, clinical multiparametric endorectal coil MRI in the NCI Molecular Imaging Clinic within 4 months of the PET scan.

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