Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
Status:
Completed
Trial end date:
2017-09-17
Target enrollment:
Participant gender:
Summary
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor
of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC), as a PET imaging biomarker
of prostate cancer detection and aggressiveness at initial diagnosis. PSMA is a well
characterized histological marker of prostate cancer tumor aggressiveness but a quantitative
non-invasive method for PSMA detection and monitoring is not currently available. Development
of such an imaging biomarker would be useful to differentiate indolent from aggressive
prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies.
The investigators preliminary first-in-human studies demonstrate high specific DCFBC uptake
in metastatic prostate cancer and feasibility for prostate cancer imaging. The investigators
propose to study patients initially diagnosed with biopsy-positive prostate cancer to
determine if DCFBC uptake and location by PET imaging will be positively correlated with
prostate cancer by prostatectomy tissue step-section analysis. DCFBC uptake at sites of
suspected metastatic disease will be compared to conventional imaging modalities (CT, bone
scan) and biopsy results when available. In addition, DCFBC-PET uptake quantification will be
compared with expression levels of PSMA and other prostate cancer relevant markers (PSA,
Ki-67, TMPRSS2-ERG) by prostate tissue immunohistochemistry analysis and compared with
clinical prognostic markers (PSA, Gleason score, clinical stage, Partin tables derived
prediction of pathologic stage).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins