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A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer

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: NCT03373006
Recruitment Status : Enrolling by invitation
First Posted : December 14, 2017
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Desert Medical Imaging

Brief Summary:
To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal therapy cohort.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Axumin PET/CT Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Diagnostic
Official Title: A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Laser Focal Therapy of Intermediate Risk Localized Prostate Cancer
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Men with Gleason Score 7 prostate cancer
Men seeking focal therapy for Gleason Score 7 prostate cancer will receive Axumin PET/CT imaging to detect metastasis which will result in exclusion from laser focal therapy.
Drug: Axumin PET/CT
Synthetic amino acid uptake agent injection followed by imaging
Other Name: PET/CT scan




Primary Outcome Measures :
  1. Detection of metastases [ Time Frame: One day ]
    Positive Axumin PET/CT



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men with Gleason 7 prostate cancer (3+4 or 4+3)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male, 45 years of age or older.
  2. Diagnosis of prostate adenocarcinoma.
  3. Clinical stage T1a, T1b, T1c, T2a, T2b orT2c.
  4. Gleason score of 7 (3+4 or 4+3).
  5. PSA density less than 0.375.
  6. One, two, or three tumor suspicious regions identified on multiparametric MRI.
  7. Negative radiographic indication of extra-capsular extent.
  8. Karnofsky performance status of at least 70.
  9. Estimated survival of 5 years or greater, as determined by treating physician.
  10. Tolerance for anesthesia/sedation.
  11. Ability to give informed consent.

Exclusion Criteria:

  1. Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
  2. Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. ( (http://www.urospec.com/uro/Forms/ipss.pdf)
  3. History of other Primary non-skin malignancy within previous three years.
  4. Diabetes.
  5. Smoker.

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): NCT03373006


Locations
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United States, California
Desert Medical Imaging
Indian Wells, California, United States, 92210
Sponsors and Collaborators
Desert Medical Imaging
Investigators
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Principal Investigator: John F Feller, MD Medical DIrector, Radiation Safety Officer
Study Director: Bernadette M Greenwood, BSc., PG Cert. Chief Research Officer

Publications:

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Responsible Party: Desert Medical Imaging
ClinicalTrials.gov Identifier: NCT03373006     History of Changes
Other Study ID Numbers: DMI Axumin-001
Protocol. No: 20171334 ( Other Identifier: Western IRB (WIRB) )
Study No: 1176339 ( Other Identifier: Western IRB (WIRB) )
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Present at scientific meetings as anonymized data, anonymize reports for case studies.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Within one year of completing of patient #20.
Access Criteria: Attendees at CME courses and researchers visiting Desert Medical Imaging may view data from our spreasdsheets and PACS. Case reports and anonymized data will be shared at scientific meetings.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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