FACBC Outcomes for Post Prostatectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Ashesh B Jani, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01666808
First received: August 14, 2012
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: FACBC
Radiation: Radiation therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Failure-free Survival [ Time Frame: 3-Year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 162
Study Start Date: September 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FACBC PET scan
A trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.
Drug: FACBC
FACBC is given intravenously prior to PET scan
Other Name: anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid
Active Comparator: Radiation therapy
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
External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.
Other Name: Intensity-modulated radiotherapy (IMRT)

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666808

Contacts
Contact: Ashesh B Jani, MD, MSEE 404-778-3827 abjani@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ashesh Jani, MD, MSEE    404-778-3827    abjani@emory.edu   
Sub-Investigator: David Schuster, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Ashesh B Jani, MD, MSEE Emory University
Principal Investigator: David M Schuster, MD Emory University
  More Information

No publications provided

Responsible Party: Ashesh B Jani, MD, Associate Professor & Residency Program Director, Emory University
ClinicalTrials.gov Identifier: NCT01666808     History of Changes
Other Study ID Numbers: IRB00057680, 1R01CA169188-01
Study First Received: August 14, 2012
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014