Clinical Trial · NCT02603965

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

Overview

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.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Phase

Phase 1

Contacts

Madhukar Thakur, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02603965

Eligibility

Inclusion

Have intermediate or high-risk PC as defined by \>= T2b disease, or Gleason score \>= 7 or prostate-specific antigen (PSA) \>= 10 ng/dL
Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection
Biopsy confirmed presence of adenocarcinoma of the prostate gland
Scheduled to undergo radical prostatectomy with pelvic lymph node dissection (either open or robotic)

Exclusion

Participating would significantly delay the scheduled standard of care therapy
Administered a radioisotope within 10 physical half-lives prior to study drug injection