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

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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

Tracking Information
First Submitted Date  ICMJE January 15, 2016
First Posted Date  ICMJE February 11, 2016
Results First Submitted Date  ICMJE October 31, 2018
Results First Posted Date  ICMJE January 28, 2019
Last Update Posted Date January 28, 2019
Actual Study Start Date  ICMJE June 1, 2016
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2019)
  • 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.
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
  • 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
  • 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
  • The rate of detection of 1) local and pelvic disease and 2) distant metastases 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 18F-fluciclovine PET CT
Single intravenous administration of 18F-fluciclovine PET CT.
Intervention: Drug: 18F-fluciclovine PET CT
Publications * Savir-Baruch B, Lovrec P, Solanki AA, Adams WH, Yonover PM, Gupta G, Schuster DM. Fluorine-18-Labeled Fluciclovine PET/CT in Clinical Practice: Factors Affecting the Rate of Detection of Recurrent Prostate Cancer. AJR Am J Roentgenol. 2019 Oct;213(4):851-858. doi: 10.2214/AJR.19.21153. Epub 2019 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2019)
221
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2016)
330
Actual Study Completion Date  ICMJE November 1, 2017
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02680041
Other Study ID Numbers  ICMJE BED003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Blue Earth Diagnostics
Study Sponsor  ICMJE Blue Earth Diagnostics
Collaborators  ICMJE
  • American College of Radiology
  • IND 2 Results LLC
  • Syne Qua Non Limited
Investigators  ICMJE
Study Chair: Umar Mahmood, MD, PhD Harvard Medical School
Study Director: Peter Gardiner, MB ChB, MRCP, FFPM Blue Earth Diagnostics
PRS Account Blue Earth Diagnostics
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP