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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Positron Emission Tomography and Computed Tomography Scan; Radiation: Copper Cu 64 TP3805

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02989623

R01CA157372 (U.S. NIH Grant/Contract)

15F.264

JT 7709 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)

Experimental group

Description:

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.

Treatment:

Radiation: Copper Cu 64 TP3805

Procedure: Positron Emission Tomography and Computed Tomography Scan