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Trial record 68 of 962 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

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

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

Condition or disease Intervention/treatment
Patients With Prostate Cancer Diagnostic Test: Pelvic CT or MRI + MDP bone scan + or - 18F-NaF PET/CT(SOC)

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.

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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Case-Only
Time Perspective: Prospective
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.
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male subjects age 18-89
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.


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): NCT03527199


Contacts
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Contact: Medhat M Osman, MD.PhD 314-652-4100 medhat.osman@va.gov

Sponsors and Collaborators
Medhat Osman
Blue Earth Diagnostics
Investigators
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Principal Investigator: Medhat M Osman, MD,PhD St. Louis VA Helathcare System

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Responsible Party: Medhat Osman, MD, PhD, Attending Physician at St. Louis VA Healthcare System, Saint Louis VA Medical Center
ClinicalTrials.gov Identifier: NCT03527199     History of Changes
Other Study ID Numbers: 1201372
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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