18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment (LOCATE)

January 2, 2019 updated by: Blue Earth Diagnostics

The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment

This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90048
        • Tower Urology
      • San Diego, California, United States, 92123
        • Genesis Research, LLC
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Roudebush VA Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Coastal Urology Associates
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • Manhattan Medical Research
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Urologic Consultants of SE Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah, Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
  • Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
  • Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second confirmatory level of >0.2 ng/mL
  • Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
  • Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis).
  • Being considered for salvage therapy
  • Any non-surgical local treatment such as previous cryotherapy, external beam radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.
  • Previous brachytherapy treatment will have occurred at least 2 years in the past
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)
  • Androgen deprivation therapy (ADT) in the past 3 months
  • History of bilateral orchidectomy
  • Inability to tolerate 18F-fluciclovine PET/CT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-fluciclovine PET CT
Single intravenous administration of 18F-fluciclovine PET CT.
Drug: 18F-fluciclovine PET CT
Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment
Other Names:
  • FACBC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
Time Frame: 2-22 days post PET CT
The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT
2-22 days post PET CT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
Time Frame: 6 months

The change of management will be based on referring physician questionnaires completed pre- 18F-fluciclovine PET/CT and changes reported at 6 month follow-up.

Investigators were instructed to assess any clinically significant change from the revised management plan.
6 months
The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population
Time Frame: 1 week
The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT
1 week
The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population
Time Frame: 1 week
The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally
1 week
The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy
Time Frame: 6 months
Based on the ratio of positive findings in the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI
6 months
The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy
Time Frame: 6 months
Based on the ratio of positive findings outside the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blue Earth Diagnostics

Collaborators

American College of Radiology
Syne Qua Non Limited
IND 2 Results LLC

Investigators

  • Study Chair: Umar Mahmood, MD, PhD, Harvard Medical School (HMS and HSDM)
  • Study Director: Peter Gardiner, MB ChB, MRCP, FFPM, Blue Earth Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 11, 2016

Study Record Updates

Last Update Posted (Actual)

January 28, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BED003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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