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

NCT02603965 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-05-02

No results posted yet for this study

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

Interventions

RADIATION

Copper Cu 64 TP3805

Given IV

PROCEDURE

Positron Emission Tomography

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

PROCEDURE

Computed Tomography

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

PROCEDURE

Radical Prostatectomy

Undergo radical prostatectomy

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Madhukar Thakur, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02603965 on ClinicalTrials.gov