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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989623
• Other study ID #: 15F.264
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: April 25, 2019

Study information

• Verified date: June 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 25, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Copper Cu 64 TP3805
Given Intravenously

Procedure:
• Positron Emission Tomography and Computed Tomography Scan
Undergo copper Cu 64 TP3805 PET/CT scan

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate cancer detection within the prostate gland by copper Cu 64 TP3805 PET	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.	Up to 3 years
Secondary	Incidence of multiple lesions in an individual patient	Generalized Estimating Equations will be utilized.	Up to 3 years

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital