Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes
NCT ID: NCT03762759
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2019-05-10
2025-12-31
Brief Summary
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Detailed Description
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I. Improve the outcomes of post-prostatectomy radiotherapy prostate cancer patients via selection and treatment optimization with advanced molecular imaging with dose escalation.
II. Establish the role of advanced molecular imaging with fluciclovine F18 (fluciclovine \[18F\]) and gallium Ga68-labeled prostate specific membrane antigen PSMA-11 (68Ga-PSMA) PET/CT in influencing post-prostatectomy radiotherapy decision-making.
III. Establish the role of advanced molecular imaging with fluciclovine 18F or 68Ga-PSMA in altering radiotherapy treatment volumes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive fluciclovine F18 intravenously (IV) and undergo a PET/CT over approximately 30 minutes.
ARM II: Patients receive 68Ga-PSMA IV, wait 60 minutes, then undergo a PET/CT over approximately 30 minutes.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (fluciclovine F18, PET/CT)
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Computed Tomography
Undergo PET/CT
Fluciclovine F18
Given IV
Positron Emission Tomography
Undergo PET/CT
Arm II (68Ga-PSMA, PET/CT)
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
Computed Tomography
Undergo PET/CT
Gallium Ga68-labeled PSMA-11
Given IV
Positron Emission Tomography
Undergo PET/CT
Interventions
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Computed Tomography
Undergo PET/CT
Fluciclovine F18
Given IV
Gallium Ga68-labeled PSMA-11
Given IV
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Detectable prostate-specific antigen (PSA)
* Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
* No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan
* No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis
* Willingness to undergo pelvic radiotherapy
Exclusion Criteria
* Inability to undergo fluciclovine or Ga-PSMA PET-CT
* Definitive findings of systemic metastasis on conventional imaging or biopsy
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
* Severe acute co-morbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
* Transmural myocardial infarction within the last 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
* Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
18 Years
MALE
No
Sponsors
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Telix Pharmaceuticals (Innovations) Pty Limited
INDUSTRY
National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
Emory University
OTHER
Responsible Party
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Ashesh B Jani
Principal Investigator
Principal Investigators
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Ashesh Jani, MD, MSEE
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Grady Health System
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2018-02702
Identifier Type: REGISTRY
Identifier Source: secondary_id
RAD4516-18
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00106863
Identifier Type: -
Identifier Source: org_study_id
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