Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery
|ClinicalTrials.gov Identifier: NCT02603965|
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : October 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Adenocarcinoma Stage IIB Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer||Radiation: Copper Cu 64 TP3805 Procedure: Positron Emission Tomography Procedure: Computed Tomography Procedure: Radical Prostatectomy Other: Laboratory Biomarker Analysis||Phase 1|
I. To assess the ability of Cu-64-TP3805 to detect prostate cancer (PC) within the prostate gland, as compared with whole mount step-sectioned surgical pathology of the prostate after radical prostatectomy.
Patients receive copper Cu 64 TP3805 intravenously (IV) and undergo PET/computed tomography (CT) at 30 minutes and 2 hours post-injection. Patients then undergo radical prostatectomy within 1 to 3 weeks after scans.
After completion of study, patients are followed up at 24 hours.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men Undergoing Radical Prostatectomy|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Diagnostic (Cu 64 TP3805 PET/CT)
Patients receive copper Cu 64 TP3805 IV and undergo PET/CT at 30 minutes and 2 hours post-injection. Patients then undergo radical prostatectomy within 1 to 3 weeks after scans.
Radiation: Copper Cu 64 TP3805
Other Name: Cu-64-TP3805
Procedure: Positron Emission Tomography
Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT
Procedure: Computed Tomography
Undergo Cu-64-TP3805 PET/CT (Computed Tomography)
Procedure: Radical Prostatectomy
Undergo radical prostatectomy
Other Name: Prostatovesiculectomy
Other: Laboratory Biomarker Analysis
- Detection rate of Cu-64 PET imaging of PC [ Time Frame: Baseline (at time of surgery) ]The proportion of lesions detected with Cu-64 PET will be determined and compared with tumor maps derived from the whole mount step sectioned surgical pathology analysis of the radical prostatectomy specimen after surgery. 95% confidence intervals will be calculated. As a secondary analysis, a generalized estimating equations will be utilized to account for multiple lesions in an individual patient.
- Incidence of adverse events [ Time Frame: Up to 30 days post Cu-64-TP3805 injection procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603965
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Madhukar Thakur, MD||Thomas Jefferson University|