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

NCT02603965 | Completed Phase 1 DMC

• 4 other identifiers: 13F.4122013-048NCI-2015-01533JT 2479
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (at time of surgery)

• Incidence of adverse events

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

Study Arms (1)

Diagnostic (Cu 64 TP3805 PET/CT)

EXPERIMENTAL

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.

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

Interventions

Copper Cu 64 TP3805 RADIATION

Given IV

Also known as: Cu-64-TP3805

Diagnostic (Cu 64 TP3805 PET/CT)

Positron Emission Tomography PROCEDURE

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

Also known as: Medical Imaging, Positron Emission Tomography Scan, PET SCAN, proton magnetic resonance spectroscopic imaging

Diagnostic (Cu 64 TP3805 PET/CT)

Computed Tomography PROCEDURE

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

Also known as: Computerized Axial Tomography, CT SCAN

Diagnostic (Cu 64 TP3805 PET/CT)

Radical Prostatectomy PROCEDURE

Undergo radical prostatectomy

Also known as: Prostatovesiculectomy

Diagnostic (Cu 64 TP3805 PET/CT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (Cu 64 TP3805 PET/CT)

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy; X-Rays

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Madhukar Thakur, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 13, 2015
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 2, 2025

Record last verified: 2025-05

Locations

US (1)