Imaging of Residual Tumor During Prostatectomy

NCT01173146 | Withdrawn DMC

• 1 other identifier: PCA-002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

Primary prostate cancer undergoing prostatectomy

Outcome Measures

Primary Outcomes (2)

• Efficacy of ProstaFluor® measured by Margin positivity after surgery (Phase II)

  Is residual disease present in subject after surgery?

  2 weeks after surgery for each patient

• Safety of Prostafluor® (Phase I)

  Testing for adverse reactions to Prostafluor

  6 weeks after surgery for each patient

Secondary Outcomes (1)

• Binding of ProstaFluor® to Prostate Cells as Measured in Pathology Laboratory After Prostatectomy

  96 hours after surgery

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing prostatectomy for prostate cancer.

You may qualify if:

• Diagnosis of Prostate Cancer
• Plan for Prostatectomy
• Signed informed consent

You may not qualify if:

• Informed consent not obtained

Sponsors & Collaborators

• Spectros Corporation: lead
• Vanderbilt University: collaborator
• Cornell University: collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David Benaron, MD

  Spectros Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 30, 2010
• Study Start: December 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 25, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)