Prostate AdenocarcinomaPhase 1NCT02603965
Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery
A Phase 1 study testing Copper Cu 64 TP3805, Positron Emission Tomography and Computed Tomography in people with Prostate Adenocarcinoma and Stage IIB Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- What is being tested?
- Copper Cu 64 TP3805, Positron Emission Tomography and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men Undergoing Radical Prostatectomy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
- Being tested
- Copper Cu 64 TP3805, Positron Emission Tomography, Computed Tomography, Radical Prostatectomy, Laboratory Biomarker Analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper Cu 64 TP3805Radiation
Also called Cu-64-TP3805
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography Scan, PET SCAN, proton magnetic resonance spectroscopic imaging
Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT
Computed TomographyProcedure or surgery
Also called Computerized Axial Tomography, CT SCAN
Undergo Cu-64-TP3805 PET/CT (Computed Tomography)
Radical ProstatectomyProcedure or surgery
Also called Prostatovesiculectomy
Undergo radical prostatectomy
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Copper Cu 64 TP3805; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Procedure: Radical Prostatectomy; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at time of surgery)
Incidence of adverse events
Measured: Up to 30 days post Cu-64-TP3805 injection procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Madhukar Thakur, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603965
- Sponsor's protocol ID
- 13F.412
- Other IDs
- 2013-048, NCI-2015-01533, JT 2479
- Status last verified
- May 2025
- First submitted
- 4 Nov 2015
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02603965
- Acronym / sponsor ID
- 13F.412
- Conditions
- Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Cu 64 TP3805 PET/CT) | Experimental | Radiation: Copper Cu 64 TP3805, Procedure: Positron Emission Tomography, Procedure: Computed Tomography, Procedure: Radical Prostatectomy, Other: Laboratory Biomarker AnalysisPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper Cu 64 TP3805Also: Cu-64-TP3805Given IV | Radiation | Diagnostic (Cu 64 TP3805 PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography Scan, PET SCAN, proton magnetic resonance spectroscopic imagingUndergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT | Procedure or surgery | Diagnostic (Cu 64 TP3805 PET/CT) |
| Computed TomographyAlso: Computerized Axial Tomography, CT SCANUndergo Cu-64-TP3805 PET/CT (Computed Tomography) | Procedure or surgery | Diagnostic (Cu 64 TP3805 PET/CT) |
| Radical ProstatectomyAlso: ProstatovesiculectomyUndergo radical prostatectomy | Procedure or surgery | Diagnostic (Cu 64 TP3805 PET/CT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (Cu 64 TP3805 PET/CT) |
Primary outcome
Detection rate of Cu-64 PET imaging of PC
Time frame: Baseline (at time of surgery)
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.
Incidence of adverse events
Time frame: Up to 30 days post Cu-64-TP3805 injection procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar Thakur, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Copper Cu 64 TP3805, Positron Emission Tomography and Computed Tomography in people with Prostate Adenocarcinoma and Stage IIB Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of Cu-64 PET imaging of PC (time frame: Baseline (at time of surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.