FACBC for Recurrent Prostate Cancer

Completed · Phase 2

Conditions studied: Recurrent Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01808222

Run by

David M. Schuster, MD

People needed

25

Starts

2013-11-01

Expected to finish

2017-09-13

Last updated by the study team

2019-01-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 non-prostatectomy therapy for localized disease.
• In the case of cryotherapy, external beam radiation, or High-Intensity Focused Ultrasound (HiFU) the procedure will have occurred at least one year in the past. In the case of brachytherapy, 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: the Radiation Therapy Oncology Group (RTOG) - American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix criteria of nadir PSA +2, and absolute PSA ≥ 4.0 ng/ml.with any doubling time (DT) or with PSA 2.0-3.99 ng/ml with DT ≤10 months
• Ability to lie still for PET scanning
• Patients must be able to provide written informed consent.

You may not qualify if…

• Age less than 18.
• Greater than T3 disease in past and/or treated with prostatectomy.
• Less than 1 year since cryotherapy,external beam radiation therapy, or HiFU or 2 years since brachytherapy..
• 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 1 month since any prior prostate biopsy (to decrease false positive uptake from inflammation).

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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