Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery
NCT ID: NCT02603965
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2013-08-31
2014-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA
NCT02989623
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
NCT06235151
Computed Tomography (CT) Scans Using CT-On-Rails™ to Pinpoint the Location of the Tumor in Treating Patients With Prostate Cancer
NCT00084526
Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer
NCT06235099
Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy
NCT06907641
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diagnostic (Cu 64 TP3805 PET/CT)
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.
Copper Cu 64 TP3805
Given IV
Positron Emission Tomography
Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT
Computed Tomography
Undergo Cu-64-TP3805 PET/CT (Computed Tomography)
Radical Prostatectomy
Undergo radical prostatectomy
Laboratory Biomarker Analysis
Correlative studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Copper Cu 64 TP3805
Given IV
Positron Emission Tomography
Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT
Computed Tomography
Undergo Cu-64-TP3805 PET/CT (Computed Tomography)
Radical Prostatectomy
Undergo radical prostatectomy
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
21 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Madhukar Thakur, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
Thomas Jefferson University Hospital
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-048
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2015-01533
Identifier Type: REGISTRY
Identifier Source: secondary_id
JT 2479
Identifier Type: OTHER
Identifier Source: secondary_id
13F.412
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.