FACBC Outcomes for Post Prostatectomy

NCT ID: NCT01666808

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2022-04-18

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FACBC PET scan

A trial group in which anti-3-\[18F\]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.

Group Type: EXPERIMENTAL

FACBC

Intervention Type: DRUG

FACBC is given intravenously prior to PET scan, radiotherapy decisions and treatment guided by PET findings

Conventional-Only Imaging

A control group whose treatment decisions will be made based on conventional imaging - bone scan and abdominopelvic CT and/or MR scan.

Group Type: ACTIVE_COMPARATOR

Radiation therapy

Intervention Type: RADIATION

External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.

Interventions

FACBC

FACBC is given intravenously prior to PET scan, radiotherapy decisions and treatment guided by PET findings

Intervention Type: DRUG

Radiation therapy

External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.

Intervention Type: RADIATION

Other Intervention Names

anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid; Intensity-modulated radiotherapy (IMRT)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ashesh B Jani

Professor & Residency Program Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashesh B Jani, MD, MSEE

Role: PRINCIPAL_INVESTIGATOR

Emory University

David M Schuster, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 33971152 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35417762 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01CA169188-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00057680

Identifier Type: -

Identifier Source: org_study_id