Clinical trial NCT02603965: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Adenocarcinoma
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2015-11-13
Enrollment: 25
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Detection rate of Cu-64 PET imaging of PC
timeFrame: Baseline (at time of surgery)
measure: Incidence of adverse events
timeFrame: Up to 30 days post Cu-64-TP3805 injection procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Madhukar Thakur, MD
role: PRINCIPAL_INVESTIGATOR
References: