Advanced Molecular Imaging With Anti-3-[18F]FACBC PET-CT to Improve the Selection and Outcomes of Prostate Cancer Patients Receiving Post-prostatectomy Radiotherapy

IRB00057680

Investigators will perform a study with 162 patients in whom there is a strong suspicion of prostate cancer that has returned to the body after having a prostatectomy. Half of these patients will have radiotherapy decision-making and delivery per the usual routine, and half of these patients will have the radiotherapy decision and volumes guided by the FACBC test (anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (anti-3- \[18F\]FACBC). The major goal of the investigation is to see whether the FACBC improves the selection and the cancer control rates of post-surgery patients with a rising PSA who undergo radiotherapy.

2012-09-01

2022-04-18

2022-04-18

Completed

Early phase I

165

Inclusion Criteria: * Adenocarcinoma of the prostate, post radical-prostatectomy Detectable PSA * ECOG/Zubrod Performance Status of 0-2 * Negative technetium 99-m MDP or F-18 PET bone scan for skeletal metastasis * CT or MR scan of abdomen and pelvis which does not suggest presence of metastatic disease outside of the pelvis * Willingness to undergo pelvic radiotherapy. Exclusion Criteria: * Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic XRT) * Inability to undergo anti-3-\[18F\]FACBC PET-CT * Age under 18 * Metastatic disease outside of pelvis on any imaging or biopsy * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years * Severe acute co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients

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2023-08-02