Expired Study
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Philadelphia, Pennsylvania 19107


Purpose:

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.


Study summary:

PRIMARY OBJECTIVES: 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.


Criteria:

Inclusion Criteria: 1. Ability to provide signed informed consent and willingness to comply with protocol requirements 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: 1. Participating would significantly delay the scheduled standard of care therapy 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


Study is Available At:


Original ID:

13F.412


NCT ID:

NCT02603965


Secondary ID:

2013-048


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Thomas Jefferson University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:Madhukar Thakur, MD
Principal Investigator
Thomas Jefferson University

Study Dates

Start Date:August 2013
Completion Date:September 2014
Completion Type:Actual
Primary Completion Date:September 2014
Primary Completion Type:Actual
Verification Date:October 2016
Last Changed Date:October 19, 2016
First Received Date:November 4, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Incidence of adverse events
Time Frame:Up to 30 days post Cu-64-TP3805 injection procedure
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Detection rate of Cu-64 PET imaging of PC
Time Frame:Baseline (at time of surgery)
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Radiation
Name:Copper Cu 64 TP3805
Description:Given IV
Arm Name:Diagnostic (Cu 64 TP3805 PET/CT)
Other Name:Cu-64-TP3805
Intervention Type:Procedure
Name:Positron Emission Tomography
Description:Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT
Arm Name:Diagnostic (Cu 64 TP3805 PET/CT)
Other Name:Medical Imaging
Intervention Type:Procedure
Name:Computed Tomography
Description:Undergo Cu-64-TP3805 PET/CT (Computed Tomography)
Arm Name:Diagnostic (Cu 64 TP3805 PET/CT)
Other Name:Computerized Axial Tomography
Intervention Type:Procedure
Name:Radical Prostatectomy
Description:Undergo radical prostatectomy
Arm Name:Diagnostic (Cu 64 TP3805 PET/CT)
Other Name:Prostatovesiculectomy
Intervention Type:Other
Name:Laboratory Biomarker Analysis
Description:Correlative studies
Arm Name:Diagnostic (Cu 64 TP3805 PET/CT)

Study Arms

Study Arm Type:Experimental
Arm Name:Diagnostic (Cu 64 TP3805 PET/CT)
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Sidney Kimmel Cancer Center at Thomas Jefferson University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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