Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery

October 19, 2016 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men Undergoing Radical Prostatectomy

This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and comparing them with cancer tissue obtained from surgery may help doctors learn whether Cu-64-TP3805 PET/CT can accurately detect prostate lesions and determine whether they are cancerous or benign, which may minimize the need for prostate biopsies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the ability of Cu-64-TP3805 to detect prostate cancer (PC) within the prostate gland, as compared with whole mount step-sectioned surgical pathology of the prostate after radical prostatectomy.

OUTLINE:

Patients receive copper Cu 64 TP3805 intravenously (IV) and undergo PET/computed tomography (CT) at 30 minutes and 2 hours post-injection. Patients then undergo radical prostatectomy within 1 to 3 weeks after scans.

After completion of study, patients are followed up at 24 hours.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Ability to provide signed informed consent and willingness to comply with protocol requirements
  2. Biopsy confirmed presence of adenocarcinoma of the prostate gland
  3. Have intermediate or high-risk PC as defined by >= T2b disease, or Gleason score >= 7 or prostate-specific antigen (PSA) >= 10 ng/dL
  4. Scheduled to undergo radical prostatectomy with pelvic lymph node dissection (either open or robotic)
  5. Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection

Exclusion Criteria:

  1. Participating would significantly delay the scheduled standard of care therapy
  2. Administered a radioisotope within 10 physical half-lives prior to study drug injection
  3. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (Cu 64 TP3805 PET/CT)
Patients receive copper Cu 64 TP3805 IV and undergo PET/CT at 30 minutes and 2 hours post-injection. Patients then undergo radical prostatectomy within 1 to 3 weeks after scans.
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Radical Prostatectomy
Undergo radical prostatectomy
Other Names:
  • Prostatovesiculectomy
Radiation: Copper Cu 64 TP3805
Given IV
Other Names:
  • Cu-64-TP3805
Procedure: Positron Emission Tomography
Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT
Other Names:
  • Positron Emission Tomography Scan
  • proton magnetic resonance spectroscopic imaging
  • PET SCAN
  • Medical Imaging
Procedure: Computed Tomography
Undergo Cu-64-TP3805 PET/CT (Computed Tomography)
Other Names:
  • Computerized Axial Tomography
  • CT SCAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of Cu-64 PET imaging of PC
Time Frame: Baseline (at time of surgery)
The proportion of lesions detected with Cu-64 PET will be determined and compared with tumor maps derived from the whole mount step sectioned surgical pathology analysis of the radical prostatectomy specimen after surgery. 95% confidence intervals will be calculated. As a secondary analysis, a generalized estimating equations will be utilized to account for multiple lesions in an individual patient.
Baseline (at time of surgery)
Incidence of adverse events
Time Frame: Up to 30 days post Cu-64-TP3805 injection procedure
Up to 30 days post Cu-64-TP3805 injection procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Madhukar Thakur, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 11, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13F.412
  • 2013-048 (Other Identifier: Thomas Jefferson University)
  • NCI-2015-01533 (Registry Identifier: NCI Clinical Trials Reporting Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Adenocarcinoma

Clinical Trials on Laboratory Biomarker Analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe