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Completed

NCT Number: NCT02989623

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copper Cu 64 TP3805

Radiation

Given Intravenously

Other names: Cu-64-TP3805

Positron Emission Tomography and Computed Tomography Scan

Procedure

Undergo copper Cu 64 TP3805 PET/CT scan

Other names: PET/CT SCAN, Positron Emission Tomography/Computed Tomography

Primary outcomes

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

    Time frame: 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 outcomes

  1. Total Incidence of Multiple Lesions in an Individual Patient

    Time frame: At 3 weeks post imaging procedure

    Generalized Estimating Equations will be utilized to provide a total number of lesions

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men With Persistently Elevated PSA

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2016
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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