Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|