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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02680041
Recruitment Status : Completed
First Posted : February 11, 2016
Results First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborators:
American College of Radiology
IND 2 Results LLC
Syne Qua Non Limited
Information provided by (Responsible Party):
Blue Earth Diagnostics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 18F-fluciclovine PET CT Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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 Name: FACBC


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680041


Locations
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Sponsors and Collaborators
Blue Earth Diagnostics
American College of Radiology
IND 2 Results LLC
Syne Qua Non Limited
Investigators
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Study Chair: Umar Mahmood, MD, PhD Harvard Medical School (HMS and HSDM)
Study Director: Peter Gardiner, MB ChB, MRCP, FFPM Blue Earth Diagnostics
  Study Documents (Full-Text)

Documents provided by Blue Earth Diagnostics:
Study Protocol  [PDF] June 7, 2017
Statistical Analysis Plan  [PDF] March 5, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Blue Earth Diagnostics
ClinicalTrials.gov Identifier: NCT02680041    
Other Study ID Numbers: BED003
First Posted: February 11, 2016    Key Record Dates
Results First Posted: January 28, 2019
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases