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

• ClinicalTrials.gov Identifier: NCT02603965
• Recruitment Status: Completed
• First Posted: November 13, 2015
• Last Update Posted: October 21, 2016
• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Tracking Information

• First Submitted Date: November 4, 2015
• First Posted Date: November 13, 2015
• Last Update Posted Date: October 21, 2016
• Study Start Date: August 2013
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 11, 2015)

• 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 ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Prostate Adenocarcinoma
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer
• Stage IV Prostate Cancer

Intervention

• Radiation: Copper Cu 64 TP3805
  Given IV
  Other Name: Cu-64-TP3805
• Procedure: Positron Emission Tomography
  Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT
  Other Names:

  • Medical Imaging
  • Positron Emission Tomography Scan
  • PET SCAN
  • proton magnetic resonance spectroscopic imaging
• Procedure: Computed Tomography
  Undergo Cu-64-TP3805 PET/CT (Computed Tomography)
  Other Names:

  • Computerized Axial Tomography
  • CT SCAN
• Procedure: Radical Prostatectomy
  Undergo radical prostatectomy
  Other Name: Prostatovesiculectomy
• Other: Laboratory Biomarker Analysis
  Correlative studies

Study Arms

Experimental: 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.

Interventions:

• Radiation: Copper Cu 64 TP3805
• Procedure: Positron Emission Tomography
• Procedure: Computed Tomography
• Procedure: Radical Prostatectomy
• Other: Laboratory Biomarker Analysis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 11, 2015): 25
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2014
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02603965
• Other Study ID Numbers: 13F.412; 2013-048 ( Other Identifier: Thomas Jefferson University ); NCI-2015-01533 ( Registry Identifier: NCI Clinical Trials Reporting Program )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
• Study Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborators: National Institutes of Health (NIH)

Investigators

• Principal Investigator: Madhukar Thakur, MD; Thomas Jefferson University

• PRS Account: Thomas Jefferson University
• Verification Date: October 2016