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

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ClinicalTrials.gov Identifier: NCT02989623
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
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:

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 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:
  • PET/CT SCAN
  • 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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT02989623


Contacts
Contact: Madhukar Thakur, PhD 215-503-7874

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Madhukar Thakur, PhD    215-503-7874      
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Madhukar Thakur, PhD Thomas Jefferson University

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02989623     History of Changes
Other Study ID Numbers: 15F.264
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs