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

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ClinicalTrials.gov Identifier: NCT02603965
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : October 21, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Stage IIB Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer Radiation: Copper Cu 64 TP3805 Procedure: Positron Emission Tomography Procedure: Computed Tomography Procedure: Radical Prostatectomy Other: Laboratory Biomarker Analysis Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 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 Undergoing Radical Prostatectomy
Study Start Date : August 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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.
 Radiation: Copper Cu 64 TP3805
Given IV
Other Name: Cu-64-TP3805

Procedure: Positron Emission Tomography
Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT
Other Names:
  • Medical Imaging
  • Positron Emission Tomography Scan
  • PET SCAN
  • proton magnetic resonance spectroscopic imaging

Procedure: Computed Tomography
Undergo Cu-64-TP3805 PET/CT (Computed Tomography)
Other Names:
  • Computerized Axial Tomography
  • CT SCAN

Procedure: Radical Prostatectomy
Undergo radical prostatectomy
Other Name: Prostatovesiculectomy

Other: Laboratory Biomarker Analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Incidence of adverse events [ Time Frame: Up to 30 days post Cu-64-TP3805 injection procedure ]

Eligibility Criteria
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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:

  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
Contacts and Locations
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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): NCT02603965


Locations
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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)
Investigators
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Principal Investigator: Madhukar Thakur, MD Thomas Jefferson University
More Information
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Additional Information:

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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02603965    
Other Study ID Numbers: 13F.412
2013-048 ( Other Identifier: Thomas Jefferson University )
NCI-2015-01533 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
 Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs