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

Primary Purpose

Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Copper Cu 64 TP3805

Positron Emission Tomography

Computed Tomography

Radical Prostatectomy

Laboratory Biomarker Analysis

About this trial

This is an interventional diagnostic trial for Prostate Adenocarcinoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Ability to provide signed informed consent and willingness to comply with protocol requirements
Biopsy confirmed presence of adenocarcinoma of the prostate gland
Have intermediate or high-risk PC as defined by >= T2b disease, or Gleason score >= 7 or prostate-specific antigen (PSA) >= 10 ng/dL
Scheduled to undergo radical prostatectomy with pelvic lymph node dissection (either open or robotic)
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

Sites / Locations

Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (Cu 64 TP3805 PET/CT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Detection rate of Cu-64 PET imaging of PC

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.

Incidence of adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT02603965

First Posted

November 4, 2015

Last Updated

October 19, 2016

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT02603965

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (Cu 64 TP3805 PET/CT)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Radiation

Intervention Name(s)

Copper Cu 64 TP3805

Other Intervention Name(s)

Cu-64-TP3805

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

Medical Imaging, Positron Emission Tomography Scan, PET SCAN, proton magnetic resonance spectroscopic imaging

Intervention Description

Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

Computerized Axial Tomography, CT SCAN

Intervention Description

Undergo Cu-64-TP3805 PET/CT (Computed Tomography)

Intervention Type

Procedure

Intervention Name(s)

Radical Prostatectomy

Other Intervention Name(s)

Prostatovesiculectomy

Intervention Description

Undergo radical prostatectomy

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Detection rate of Cu-64 PET imaging of PC

Description

Time Frame

Baseline (at time of surgery)

Title

Incidence of adverse events

Time Frame

Up to 30 days post Cu-64-TP3805 injection procedure

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to provide signed informed consent and willingness to comply with protocol requirements Biopsy confirmed presence of adenocarcinoma of the prostate gland Have intermediate or high-risk PC as defined by >= T2b disease, or Gleason score >= 7 or prostate-specific antigen (PSA) >= 10 ng/dL Scheduled to undergo radical prostatectomy with pelvic lymph node dissection (either open or robotic) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Madhukar Thakur, MD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Links:

URL

http://hospitals.jefferson.edu/

Description

Thomas Jefferson University Hospital

Learn more about this trial

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

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