FACBC Outcomes for Post Prostatectomy

NCT01666808 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB000576801R01CA169188-01
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Failure-free Survival

  Definition of failure is: serum PSA value of 0.2ng/mL or more above the postradiotherapy nadir followed by another higher value, a continued rise in the serum PSA despite radiotherapy (RT), initiation of systemic therapy after completion of RT, or clinical progression.

  3-Year post-intervention

Secondary Outcomes (14)

• Decision Changes Regarding Radiotherapy Versus no Radiotherapy

  Average of 1 week post-intervention

• Decision Changes Regarding Whole-pelvis Versus Local Fields

  Average of 1 week post-intervention

• Total Number of Decision Changes

  Average of 1 week post-intervention

• Prostate Bed Clinical Target Volume (CTV)

  Average of 1 month post-intervention

• Prostate Bed Planning Target Volume (PTV)

  Average of 1 month post-intervention

Study Arms (2)

FACBC PET scan

EXPERIMENTAL

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

Drug: FACBC

Conventional-Only Imaging

ACTIVE COMPARATOR

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

Radiation: Radiation therapy

Interventions

FACBC DRUG

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

Also known as: anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid

FACBC PET scan

Radiation therapy RADIATION

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

Also known as: Intensity-modulated radiotherapy (IMRT)

Conventional-Only Imaging

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• 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.

  PMID: 33971152 RESULT

• 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.

  PMID: 35417762 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18; Radiotherapy; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Results Point of Contact

• Title: Dr. Ashesh Jani
• Organization: Emory University

abjani@emory.edu

404-778-3827

Study Officials

• Ashesh B Jani, MD, MSEE

  Emory University

  PRINCIPAL INVESTIGATOR

• David M Schuster, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Residency Program Director

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 16, 2012
• Study Start: September 1, 2012
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: August 2, 2023
• Results First Posted: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)