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Prostate Cancer Patients With Biochemical Recurrence

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ClinicalTrials.gov Identifier: NCT03527199
Recruitment Status : Not yet recruiting
First Posted : May 17, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
Blue Earth Diagnostics
Information provided by (Responsible Party):
Medhat Osman, Saint Louis VA Medical Center

Tracking Information
First Submitted Date May 4, 2018
First Posted Date May 17, 2018
Last Update Posted Date August 20, 2018
Estimated Study Start Date September 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2018)
In the settings of BCR, detection rate of 18F- Fluciclovine will be compared to that of standard of care (SOC) (pelvic CT or MRI plus 99mTc-MDP bone scan). [ Time Frame: 3-6months from acquiring Fluciclovine exam ]
Detection rate of 18F- Fluciclovine PET/CT will be compared to current standard of care imaging with or without 18F-NaF PET/CT based on all available clinical follow up data including histological reference standard when biopsy of suspected lesion(s) is performed.
Original Primary Outcome Measures
 (submitted: May 4, 2018)
To assess, in the settings of BCR, detection rate of 18F- Fluciclovine compared to that of standard of care (SOC) (pelvic CT or MRI plus 99mTc-MDP bone scan). [ Time Frame: 3-6months from acquiring Fluciclovine exam ]
Detection rate of 18F- Fluciclovine PET/CT will be compared to current standard of care imaging with or without 18F-NaF PET/CT based on all available clinical follow up data including histological reference standard when biopsy of suspected lesion(s) is performed.
Change History Complete list of historical versions of study NCT03527199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 17, 2018)
In the settings of BCR with negative standard of care 99mTc-MDP bone scan, detection rate of 18F- Fluciclovine wiill be compared to that of standard of care pelvic CT or MRI plus 18F-NaF PET/CT. [ Time Frame: 3-6months from acquiring Fluciclovine exam ]
In the setting of PCa patients with BCR, documenting a higher detection rate for 18F- Fluciclovine PET/CT compared to current standard of care imaging modalities could result in future use of 18F- Fluciclovine PET/CT as a "one stop shop" for those patients.
Original Secondary Outcome Measures
 (submitted: May 4, 2018)
To assess, in the settings of BCR with negative standard of care 99mTc-MDP bone scan, detection rate of 18F- Fluciclovine compared to that of standard of care pelvic CT or MRI plus 18F-NaF PET/CT. [ Time Frame: 3-6months from acquiring Fluciclovine exam ]
In the setting of PCa patients with BCR, documenting a higher detection rate for 18F- Fluciclovine PET/CT compared to current standard of care imaging modalities could result in future use of 18F- Fluciclovine PET/CT as a "one stop shop" for those patients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prostate Cancer Patients With Biochemical Recurrence
Official Title Prospective Comparison of Pelvic CT or MRI Plus Bone Scanning With 99mTc-MDP Bone Scan and/or 18F-NaF PET/CT to 18F- Fluciclovine PET/CT in VA Prostate Cancer Patients With BCR.
Brief Summary Evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques within 30 days of the standard of care imaging study and a 6 month phone follow-up
Detailed Description When BCR is present, detection of recurrence as well as the location, distribution and number of metastatic sites would determine the choice of subsequent management. In the search of malignancy in patients with BCR, standard of care tests include Pelvic CT or MRI (to look for recurrence and/or pelvic nodal metastases) and a planar bone scan to look for skeletal metastases. However, standard of care testing has a low diagnostic yield of only 11% of patients for visualizing sites of disease (5). Thus, there is a clear need for better imaging approaches. 18F-Fluciclovine is a synthetic amino acid PET tracer approved by the Food and Drug Administration in June of 2016 for the detection of sites of recurrence in men with rising prostate-specific antigen levels after prior primary treatment of prostate cancer (6), based on its diagnostic performance (7,8). However, there is a gap in the literature regarding prospective studies evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques. Therefore, 18F-Fluciclovine has already been approved by the FDA and covered CMS and insurance companies but is yet to be included in the NCCN guidelines in the work up of PCa patients with BCR.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Male subjects age 18-89
Condition Patients With Prostate Cancer
Intervention Diagnostic Test: Pelvic CT or MRI + MDP bone scan + or - 18F-NaF PET/CT(SOC)
Standard of care-Pelvic CT or MRI and MDP bone scan + or - 18F-NaF PET/CT
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 4, 2018)
65
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age >18 and ≤89
  2. History of Prostate Cancer which required surgical resection or radiation
  3. Documented Biochemical recurrence defined as a positive PSA any time after the initial diagnosis of prostate cancer which at that time required surgical resection or radiation and then had a negative result to a post treatment PSA.
  4. Patient undergoing standard of care work up pelvic CT or MRI, 99mTc-MDP bone scan, and F18 NaF PET/CT.

Exclusion Criteria:

1. BCR with negative 99mTc-MDP bone scan but 18F-NaF PET/CT was not able to be done.

Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Male
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Medhat M Osman, MD.PhD 314-652-4100 medhat.osman@va.gov
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03527199
Other Study ID Numbers 1201372
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medhat Osman, Saint Louis VA Medical Center
Study Sponsor Medhat Osman
Collaborators Blue Earth Diagnostics
Investigators
Principal Investigator: Medhat M Osman, MD,PhD St. Louis VA Helathcare System
PRS Account Saint Louis VA Medical Center
Verification Date August 2018