FACBC PET/CT for Recurrent Prostate Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2015-07-31

Brief Summary

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Hypothesis:Anti-\[18F\]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients.

This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called \[18\]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called \[18\]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called \[18\]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done.

Anti-\[18F\]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention.

This study will look at how the \[18\]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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FACBC PET-CT and ProstaScint CT

Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT.

Group Type OTHER

FACBC

Intervention Type DRUG

Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan

ProstaScinct

Intervention Type OTHER

ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.

Interventions

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FACBC

Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan

Intervention Type DRUG

ProstaScinct

ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.

Intervention Type OTHER

Other Intervention Names

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Fluciclovine In-Capromab Pendetide

Eligibility Criteria

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Inclusion Criteria

* Patients must be 18 years of age or older.
* Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease.
* In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump."
* Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy.
* Ability to lie still for PET scanning
* Patients must be able to provide written informed consent.

Exclusion Criteria

* Age less than 18.
* Greater than T3 disease in past
* Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy.
* Does not meet above criteria of suspicious PSA elevation
* Inability to lie still for PET scanning
* Cannot provide written informed consent.
* Bone scan findings characteristic for metastatic prostate carcinoma
* Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No