Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: Copper Cu 64 TP3805; Procedure: Positron Emission Tomography and Computed Tomography Scan

• Registration Number: NCT02989623
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief Summary

This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography (PET) works in detecting prostate cancer in patients with persistently elevated prostate specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound made of a radioactive agent attached to a molecule that looks like a hormone that binds to cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able to see tumors at an earlier stage than the standard of care.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect prostate cancer (PC), or absence thereof, within the prostate gland.

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-12
• Primary Completion: 2019-04-24
• Study Completion: 2019-04-25
• Results First Submitted: 2023-07-11
• Results First Submitted QC: 2025-03-17
• Results First Posted: 2025-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Ability to provide signed informed consent and willingness to comply with protocol requirements
• Persistently elevated PSA
• Scheduled for magnetic resonance imaging (MRI) fusion/transrectal ultrasound (TRUS) biopsy, followed by histology
• Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection

Exclusion Criteria

• Participating would significantly delay the scheduled standard of care therapy
• Administered a radioisotope within 10 physical half-lives prior to study drug injection
• Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)	Positron Emission Tomography and Computed Tomography Scan	Patients receive copper Cu 64 TP3805 IV over 5 minutes and 30 minutes and 2 hours later, undergo whole body Positron Emission Tomography/Computed Tomography (PET/CT) imaging over 1 hour.
Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)	Copper Cu 64 TP3805	Patients receive copper Cu 64 TP3805 IV over 5 minutes and 30 minutes and 2 hours later, undergo whole body Positron Emission Tomography/Computed Tomography (PET/CT) imaging over 1 hour.

Primary Outcome Measures

Name	Time	Method
Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET	At 3 weeks post imaging visit	The proportion of participants with lesions detected with copper Cu-64 PET will be determined with the lesion as the unit of analysis. 95% confidence intervals will be calculated.

Secondary Outcome Measures

Name	Time	Method
Total Incidence of Multiple Lesions in an Individual Patient	At 3 weeks post imaging procedure	Generalized Estimating Equations will be utilized to provide a total number of lesions

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States