Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer
NCT ID: NCT03698370
Last Updated: 2024-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2020-12-15
2022-02-11
Brief Summary
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Detailed Description
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I. To evaluate gallium Ga 68 DOTA-NeoBOMB1 (68Ga-NeoBOMB1) and gallium Ga 68 PSMA-R2 (68Ga-PSMA R2) PET/MRI for detection of recurrent prostate cancer after initial therapy in patients meeting the criterion of biochemical recurrence.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive gallium Ga 68 DOTA-NeoBOMB1 intravenously (IV) and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later.
ARM II: Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later.
After completion of study, participants are followed up at 12 months.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2
Participants receive gallium Ga 68 DOTA-NeoBOMB1 IV and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later.
Gallium Ga 68 DOTA-NeoBOMB1
Administered intravenously (IV)
Gallium Ga 68 PSMA-R2
Administered intravenously (IV)
Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)
Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later.
Gallium Ga 68 DOTA-NeoBOMB1
Administered intravenously (IV)
Gallium Ga 68 PSMA-R2
Administered intravenously (IV)
Interventions
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Gallium Ga 68 DOTA-NeoBOMB1
Administered intravenously (IV)
Gallium Ga 68 PSMA-R2
Administered intravenously (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
a. Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation.
(i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy.
(ii) Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL).
b. Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition.
(i) A rise of PSA measurement of 2 or more ng/mL over the nadir.
* Able to provide written consent.
* Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent).
Exclusion Criteria
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
* Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.
* Metallic implants (contraindicated for magnetic resonance imaging \[MRI\]).
18 Years
MALE
No
Sponsors
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Andrei Iagaru
OTHER
Responsible Party
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Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Principal Investigators
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Andrei Iagaru
Role: PRINCIPAL_INVESTIGATOR
Stanford Cancer Institute Palo Alto
Locations
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Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2018-01799
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB-46258
Identifier Type: OTHER
Identifier Source: secondary_id
PROS0089
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-46258
Identifier Type: -
Identifier Source: org_study_id
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