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
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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