CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
18F-DCFBCdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01496157
NCT01496157Phase 2Completed

Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Dec 21, 2011·Updated Aug 28, 2018

In Brief

A Phase 2 clinical trial evaluating 18F-DCFBC for Prostate Cancer. Completed, enrolled 15 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2011
Enrollment StartSep 11, 2012
Primary CompletionJan 1, 2015
Study CompletionSep 17, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.5 years ago

Interventions

18F-DCFBCdrug

A bolus of 10 mCi (370 MBq) \[9-11 mCi (333-407 MBq)\] of 18F-DCFBC will be injected into the IV line by slow IV push.