Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2013 |
| End Date: | September 2014 |
A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men Undergoing Radical Prostatectomy
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.
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.
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.
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.
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
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