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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02989623
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : June 28, 2019
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Thomas Jefferson University ( 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Copper Cu 64 TP3805 Procedure: Positron Emission Tomography and Computed Tomography Scan Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)
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
Given Intravenously
Other Name: Cu-64-TP3805

Procedure: Positron Emission Tomography and Computed Tomography Scan
Undergo copper Cu 64 TP3805 PET/CT scan
Other Names:
  • Positron Emission Tomography/Computed Tomography

Primary Outcome Measures :
  1. Prostate cancer detection within the prostate gland by copper Cu 64 TP3805 PET [ Time Frame: Up to 3 years ]
    The proportion of 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 :
  1. Incidence of multiple lesions in an individual patient [ Time Frame: Up to 3 years ]
    Generalized Estimating Equations will be utilized.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02989623

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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
National Institutes of Health (NIH)
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Principal Investigator: Madhukar Thakur, PhD Thomas Jefferson University
Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University Identifier: NCT02989623    
Other Study ID Numbers: 15F.264
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs