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FACBC for Recurrent Prostate Cancer

NCT01808222 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-01-07

Study results available
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Summary

The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-\[18F\] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA. All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate.

Conditions

  • Recurrent Prostate Cancer

Interventions

DRUG

FACBC

Participants will receive a bolus of anti-\[18F\]FACBC injected IV over 1-2 minutes. The dosage will be approximately 10.0 millicuries (mCi) (3.70 x 108 becquerel (Bq)).

Sponsors & Collaborators

  • David M. Schuster, MD

    lead OTHER

Principal Investigators

  • David M Schuster, MD · Emory University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-09-13
Completion
2017-09-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT01808222 on ClinicalTrials.gov