NCT02603965

Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery

A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men Undergoing Radical Prostatectomy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and comparing them with cancer tissue obtained from surgery may help doctors learn whether Cu-64-TP3805 PET/CT can accurately detect prostate lesions and determine whether they are cancerous or benign, which may minimize the need for prostate biopsies.

Detailed description

PRIMARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Prostate Adenocarcinoma
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Copper Cu 64 TP3805	Given IV
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	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2015-11-13
• Last updated: 2025-05-02

Locations

1 site across 1 country: United States