FACBC Outcomes for Post Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

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 radiotherapy Significant advances have been made in the technical aspects of
      surgery and of radiotherapy which have improved both the cancer control outcomes as well as
      the morbidity of treatment. Despite these significant advances, approximately 30% of patients
      treated with definitive local therapy experience recurrent disease. Recurrent disease after
      prostatectomy usually manifests with rising PSA (blood test for prostate cancer). The PSA
      level is often of limited use in differentiating local recurrence (ie. recurrence in the
      prostate bed) from recurrence outside of the prostate bed ( extra-prostatic recurrence).

      One PET radiotracer which has shown promise in the staging and restaging of patients with
      prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid
      (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher
      accuracy compared with 111Indium-capromab-pendetide in the restaging of patients with
      suspected recurrent prostate carcinoma.

      The major goal in this proposed investigation is to use advanced molecular imaging to better
      guide post-prostatectomy decision making, in terms of guiding the decision to deliver
      radiotherapy, and in terms of the exact areas treated with radiotherapy.

      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.
      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.
    

Intervention name(s): FACBC; Radiation therapy
Intervention type(s): Drug; Radiation
Intervention description(s): FACBC is given intravenously prior to PET scan, radiotherapy decisions and treatment guided by PET findings; External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.
Other intervention name(s): anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid; Intensity-modulated radiotherapy (IMRT)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment