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Imaging of Residual Tumor During Prostatectomy

NCT01173146 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2016-05-25

No results posted yet for this study

Summary

Prostate Cancer is the most common cancer in men, affecting about as many men as women diagnosed with breast cancer, and killing about as many men per year as breast cancer kills women.

The most common surgical treatment is prostatectomy, the removal of the prostate. During prostate surgery, tumor remains at the edge of the surgery, called residual tumor, in 30% of all prostatectomies. Such patients have a significantly higher risk of local recurrence of the cancer, and higher rates of death. In contrast, even patients with cancer outside of the prostate, but still nearby the prostate, do better when the margins are made clean of tumor during surgery.

The investigators propose to reduce the number of patients with residual tumor after surgery. The investigators will test in patients a fluorescent molecule that allows cancer to be detected during surgery. If this trial works as designed, the investigators will reduce the number of patients who have to receive additional treatment, such as high doses of radiation to the lower abdomen, because the amount of residual tumor left behind has been minimized. This may also lead to higher rates of survival.

This type of detection of cancer the investigators employ is called Molecular imaging. The investigators believe that molecular imaging will be the key to improved diagnosis, individualized treatment selection, and treatment monitoring.

If successful, a large human trial will be conducted after this study with a corporate imaging partner.

Conditions

Sponsors & Collaborators

  • Vanderbilt University

    collaborator OTHER

  • Cornell University

    collaborator OTHER

  • Spectros Corporation

    lead INDUSTRY

Principal Investigators

  • David Benaron, MD · Spectros Corporation

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01173146 on ClinicalTrials.gov