Clinical Trial · NCT01496157

Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer

Overview

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).

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase

Phase 1/2

Contacts

Steven P Rowe, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01496157

Eligibility

Inclusion

Patients considered as candidates for and medically fit to undergo prostatectomy
No known problems with peripheral IV or central line access
Newly diagnosed prostate cancer pathologically proven by prostate biopsy
At least 10 days after most recent prostate biopsy
Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
Prostate biopsy histology grade ≥ Gleason 3+3=6.
Able to tolerate urinary straight catheter placement

Exclusion

Hemorrhagic cystitis or active prostatitis
Serum creatinine \> 1.5 mg/dL or creatinine clearance \< 50 mL/min/1.73m2
Chemotherapy for prostate cancer
Investigational therapy for prostate cancer
Hormone deprivation therapy
No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging)
Unable to lie flat during or tolerate PET/CT
Prior pelvic external beam radiation therapy or brachytherapy