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Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer

Sponsor
Andrei Iagaru (Other)
Overall Status
Suspended
CT.gov ID
NCT03698370
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
32.5
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing participants with prostate cancer that has come back. Diagnostic procedures, such as gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gallium Ga 68 DOTA-NeoBOMB1
  • Device: Gallium Ga 68 PSMA-R2
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer
Actual Study Start Date :
Dec 15, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Gallium Ga 68 DOTA-NeoBOMB1
Administered intravenously (IV)
Other Names:
  • Ga68-NeoBOMB1

    • Device: Gallium Ga 68 PSMA-R2
    Administered intravenously (IV)
    Other Names:
  • Ga68 PSMA-R2

    		•
    Experimental: 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.

    Drug: Gallium Ga 68 DOTA-NeoBOMB1
    Administered intravenously (IV)
    Other Names:
  • Ga68-NeoBOMB1

    • Device: Gallium Ga 68 PSMA-R2
    Administered intravenously (IV)
    Other Names:
  • Ga68 PSMA-R2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of lesions detected by investigational imaging agent [Within 30 days of imaging]

      The number of lesions detected on Ga- NeoBOMB1 positron emission tomography (PET)/magnetic resonance imaging (MRI), Ga PSMA R2 PET/MRI, and conventional MR will be compared. Outcome will be reported as number of lesions detected per patient for each imaging method.

    Secondary Outcome Measures

    1. Predictive value of malignancy [After 1 year clinical follow-up]

      The predictive value of Ga- NeoBOMB1 PET/MRI and Ga PSMA R2 PET/MRI imaging will be evaluated based on biopsy and/or imaging results during 12 month standard clinical follow-up. Outcome will be reported as percentage of detected lesions that were confirmed to be malignant for each imaging method.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Biopsy proven prostate adenocarcinoma.

    • Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

    1. 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).

    1. 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 lie still for the entire imaging time.

    • 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]).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304

    Sponsors and Collaborators

    • Andrei Iagaru

    Investigators

    • Principal Investigator: Andrei Iagaru, Stanford Cancer Institute Palo Alto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrei Iagaru, Associate Professor of Radiology (Nuclear Medicine) at the Stanford University Medical Center, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03698370
    Other Study ID Numbers:
    • IRB-46258
    • NCI-2018-01799
    • IRB-46258
    • PROS0089
    First Posted:
    Oct 9, 2018
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Adenocarcinoma

    Study Results

    No Results Posted as of May 9, 2022