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

NCT02989623 | Completed Results DMC

• 3 other identifiers: 15F.264R01CA157372JT 7709
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET

  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.

  At 3 weeks post imaging visit

Secondary Outcomes (1)

• Total Incidence of Multiple Lesions in an Individual Patient

  At 3 weeks post imaging procedure

Study Arms (1)

Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)

EXPERIMENTAL

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.

Radiation: Copper Cu 64 TP3805; Procedure: Positron Emission Tomography and Computed Tomography Scan

Interventions

Copper Cu 64 TP3805 RADIATION

Given Intravenously

Also known as: Cu-64-TP3805

Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)

Positron Emission Tomography and Computed Tomography Scan PROCEDURE

Undergo copper Cu 64 TP3805 PET/CT scan

Also known as: PET/CT SCAN, Positron Emission Tomography/Computed Tomography

Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Mathew Thakur
• Organization: Thomas Jefferson University

Mathew.Thakur@Jefferson.edu

215-503-7874

Study Officials

• Madhukar Thakur, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 12, 2016
• Study Start: September 1, 2015
• Primary Completion: April 24, 2019
• Study Completion: April 25, 2019
• Last Updated: April 24, 2025
• Results First Posted: March 27, 2025

Record last verified: 2025-04

Locations

US (1)