CompletedPhase 1

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

United States25 participantsStarted 2013-08

Plain-language 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.

Who can participate

Age range21 Years

SexMALE

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Detection rate of Cu-64 PET imaging of PC

Timeframe: Baseline (at time of surgery)

Incidence of adverse events

Timeframe: Up to 30 days post Cu-64-TP3805 injection procedure

Trial details

NCT IDNCT02603965

SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

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