Clinical trial NCT01666808: FACBC Outcomes for Post Prostatectomy
Official title: Advanced Molecular Imaging With Anti-3-[18F]FACBC PET-CT to Improve the Selection and Outcomes of Prostate Cancer Patients Receiving Post-prostatectomy Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-08-16
Enrollment: 165
Sex: MALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Failure-free Survival
timeFrame: 3-Year post-intervention
Secondary outcomes:
measure: Decision Changes Regarding Radiotherapy Versus no Radiotherapy
timeFrame: Average of 1 week post-intervention
measure: Decision Changes Regarding Whole-pelvis Versus Local Fields
timeFrame: Average of 1 week post-intervention
measure: Total Number of Decision Changes
timeFrame: Average of 1 week post-intervention
measure: Prostate Bed Clinical Target Volume (CTV)
timeFrame: Average of 1 month post-intervention
measure: Prostate Bed Planning Target Volume (PTV)
timeFrame: Average of 1 month post-intervention
measure: PTV Dosimetric Endpoints
timeFrame: Average of 1 month post-intervention
measure: Rectum Dosimetric Endpoints
timeFrame: Average of 1 month post-intervention
measure: Bladder Dosimetric Endpoints
timeFrame: Average of 1 month post-intervention
measure: Rate of ≥ Grade 2 GU (Genitourinary [Renal or Urinary]) Toxicity
timeFrame: 3-Year post-intervention
measure: Rate of ≥ Grade 2 GI (Gastrointestinal) Toxicity
timeFrame: 3-Year post-intervention
measure: Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC) GU (Genitourinary) Domain Score
timeFrame: 3-Year post-intervention
measure: Expanded Prostate Cancer Index Composite (EPIC) GI (Gastrointestinal) Domain Score
timeFrame: 3-Year post-intervention
measure: Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score
timeFrame: 3-Year post-intervention
measure: Expanded Prostate Cancer Index Composite (EPIC) Total Score
timeFrame: 3-Year post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Ashesh B Jani, MD, MSEE
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: David M Schuster, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jani AB, Schreibmann E, Goyal S, Halkar R, Hershatter B, Rossi PJ, Shelton JW, Patel PR, Xu KM, Goodman M, Master VA, Joshi SS, Kucuk O, Carthon BC, Bilen MA, Abiodun-Ojo OA, Akintayo AA, Dhere VR, Schuster DM. 18F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial. Lancet. 2021 May 22;397(10288):1895-1904. doi: 10.1016/S0140-6736(21)00581-X. Epub 2021 May 7.
citation: Dhere VR, Schuster DM, Goyal S, Schreibmann E, Hershatter BW, Rossi PJ, Shelton JW, Patel PR, Jani AB. Randomized Trial of Conventional Versus Conventional Plus Fluciclovine (18F) Positron Emission Tomography/Computed Tomography-Guided Postprostatectomy Radiation Therapy for Prostate Cancer: Volumetric and Patient-Reported Analyses of Toxic Effects. Int J Radiat Oncol Biol Phys. 2022 Aug 1;113(5):1003-1014. doi: 10.1016/j.ijrobp.2022.04.005. Epub 2022 Apr 11.