Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment 18f-dcfbc
Phase phase 1/phase 2
Sponsor Sidney Kimmel Comprehensive Cancer Center
Start date December 2011
End date January 2015
Trial size 24 participants
Trial identifier NCT01496157, J1191, NA_00051395

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
PET detection of primary prostate cancer
time frame: 24 months

Secondary Outcomes

Measure
PET detection of metastatic disease at initial staging
time frame: 24 months

Eligibility Criteria

Male participants from 18 years up to 90 years old.

Inclusion Criteria: 1. Newly diagnosed prostate cancer pathologically proven by prostate biopsy 2. Prostate biopsy histology grade ≥ Gleason 3+3=6. 3. Patients considered as candidates for and medically fit to undergo prostatectomy 4. At least 10 days after most recent prostate biopsy 5. No known problems with peripheral IV or central line access 6. Able to tolerate urinary straight catheter placement 7. 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. 8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Exclusion Criteria: 1. Prior pelvic external beam radiation therapy or brachytherapy 2. Chemotherapy for prostate cancer 3. Hormone deprivation therapy 4. Investigational therapy for prostate cancer 5. Hemorrhagic cystitis or active prostatitis 6. Unable to lie flat during or tolerate PET/CT 7. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer 8. No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging) 9. Serum creatinine > 1.5 mg/dL or creatinine clearance < 50 mL/min/1.73m2

Additional Information

Official title Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer
Principal investigator Steve Y. Cho, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.