Status:
COMPLETED
FACBC for Recurrent Prostate Cancer
Lead Sponsor:
David M. Schuster, MD
Conditions:
Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Prostate cancer is the most common solid tumor, with approximately 200,000 new cases diagnosed per year. Several different local therapies are available for treatment, including surgery and radiothera...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- \-
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01808222
Start Date
November 1 2013
End Date
September 13 2017
Last Update
January 7 2019
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322