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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 1

Conditions: Stage IV Prostate Cancer; Prostate Adenocarcinoma; Stage III Prostate Cancer; Stage IIB Prostate Cancer

Treatments: Procedure: Positron Emission Tomography; Radiation: Copper Cu 64 TP3805; Other: Laboratory Biomarker Analysis; Procedure: Radical Prostatectomy; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02603965

2013-048 (Other Identifier)

13F.412

NCI-2015-01533 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Diagnostic (Cu 64 TP3805 PET/CT)

Experimental group

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.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Computed Tomography

Procedure: Radical Prostatectomy

Radiation: Copper Cu 64 TP3805

Procedure: Positron Emission Tomography