FACBC PET/CT for Recurrent Prostate Cancer

David M. Schuster, MD

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Other: ProstaScinct; Drug: FACBC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00562315

IRB00006468

R01CA129356-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

STUDY NOW CLOSED for recruitment

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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128 participants in 1 patient group

FACBC PET-CT and ProstaScint CT

Other group

Description:

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.

Treatment:

Drug: FACBC

Other: ProstaScinct