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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2019-04-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Copper Cu 64 TP3805

Intervention Type RADIATION

Given Intravenously

Positron Emission Tomography and Computed Tomography Scan

Intervention Type PROCEDURE

Undergo copper Cu 64 TP3805 PET/CT scan

Interventions

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Copper Cu 64 TP3805

Given Intravenously

Intervention Type RADIATION

Positron Emission Tomography and Computed Tomography Scan

Undergo copper Cu 64 TP3805 PET/CT scan

Intervention Type PROCEDURE

Other Intervention Names

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Cu-64-TP3805 PET/CT SCAN Positron Emission Tomography/Computed Tomography

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No