Prostate CancerNCT02989623

Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA

A study testing Copper Cu 64 TP3805 and Positron Emission Tomography and Computed Tomography Scan in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Copper Cu 64 TP3805 and Positron Emission Tomography and Computed Tomography Scan
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: 1 Sep 2015to 25 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Persistently elevated PSA
Scheduled for magnetic resonance imaging (MRI) fusion/transrectal ultrasound (TRUS) biopsy, followed by histology
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

Other trials in United States

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 With Persistently Elevated PSA

This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography (PET) works in detecting prostate cancer in patients with persistently elevated prostate specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound made of a radioactive agent attached to a molecule that looks like a hormone that binds to cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able to see tumors at an earlier stage than the standard of care.

Read the detailed description

PRIMARY OBJECTIVES:

To assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect prostate cancer (PC), or absence thereof, within the prostate gland.

Conditions: Prostate Cancer
Being tested: Copper Cu 64 TP3805, Positron Emission Tomography and Computed Tomography Scan
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 Intravenously
Positron Emission Tomography and Computed Tomography ScanProcedure or surgery
Also called PET/CT SCAN, Positron Emission Tomography/Computed Tomography
Undergo copper Cu 64 TP3805 PET/CT scan

Study groups in NCT02989623
Study group	Role	What they receive
Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)	Experimental	Patients receive copper Cu 64 TP3805 IV over 5 minutes and 30 minutes and 2 hours later, undergo whole body Positron Emission Tomography/Computed Tomography (PET/CT) imaging over 1 hour. Receives: Radiation: Copper Cu 64 TP3805; Procedure: Positron Emission Tomography and Computed Tomography Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET
The proportion of participants with lesions detected with copper Cu-64 PET will be determined with the lesion as the unit of analysis. 95% confidence intervals will be calculated.
Measured: At 3 weeks post imaging visit

Secondary outcomes (1)

Total Incidence of Multiple Lesions in an Individual Patient
Generalized Estimating Equations will be utilized to provide a total number of lesions
Measured: At 3 weeks post imaging procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201525 Apr 2019

First posted12 Dec 2016 (estimated)
Study start1 Sep 2015
Primary completion24 Apr 2019
Study completion25 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies 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 N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02989623
Sponsor's protocol ID: 15F.264
Other IDs: R01CA157372, JT 7709
Status last verified: Apr 2025
First submitted: 8 Dec 2016
Last updated: 24 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 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 With Persistently Elevated PSA
ClinicalTrials.gov ID: NCT02989623
Acronym / sponsor ID: 15F.264
Conditions: Prostate Cancer
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), National Cancer Institute (NCI)
Study start: 1 Sep 2015 (actual)
Primary completion: 24 Apr 2019 (actual)
Study completion: 25 Apr 2019 (actual)
First posted: 12 Dec 2016 (estimated)
Results: Posted 27 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect prostate cancer (PC), or absence thereof, within the prostate gland.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)	Experimental	Radiation: Copper Cu 64 TP3805, Procedure: Positron Emission Tomography and Computed Tomography ScanPatients receive copper Cu 64 TP3805 IV over 5 minutes and 30 minutes and 2 hours later, undergo whole body Positron Emission Tomography/Computed Tomography (PET/CT) imaging over 1 hour.

Who may qualify

Ages: 21 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Ability to provide signed informed consent and willingness to comply with protocol requirements
Persistently elevated PSA
Scheduled for magnetic resonance imaging (MRI) fusion/transrectal ultrasound (TRUS) biopsy, followed by histology
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 Intravenously	Radiation	Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)
Positron Emission Tomography and Computed Tomography ScanAlso: PET/CT SCAN, Positron Emission Tomography/Computed TomographyUndergo copper Cu 64 TP3805 PET/CT scan	Procedure or surgery	Diagnostic (copper Cu 64 TP3805, PET/CT, biopsy)

Primary outcome

Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET
Time frame: At 3 weeks post imaging visit
The proportion of participants with lesions detected with copper Cu-64 PET will be determined with the lesion as the unit of analysis. 95% confidence intervals will be calculated.

1 secondary outcome

Total Incidence of Multiple Lesions in an Individual Patient
Time frame: At 3 weeks post imaging procedure

Results and safety

Results posted to the registry on 27 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy)	25	25

Primary outcome: Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET

Time frame: At 3 weeks post imaging visit. Count of participants. Unit: Participants

Measure	Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy) n = 25
Value	25

1 secondary outcome is reported in the full results.

Adverse events

Time frame: subjects were monitored for 24 hours post imaging for adverse events. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic (Copper Cu 64 TP3805, PET/CT, Biopsy)	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sidney Kimmel Cancer CenterLink provided by the sponsor.
Thomas Jefferson University HospitalLink provided by the sponsor.

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Enrolling by invitationObservational study
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Not yet recruitingPhase 1/2
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Recruiting
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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, PhD 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?

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 4 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 24 Apr 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET (time frame: At 3 weeks post imaging visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02989623.

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 24 Apr 2025.