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

January 9, 2024 updated by: Andrei Iagaru

68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute Palo Alto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biopsy proven prostate adenocarcinoma.

  • 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 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]).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Lesions Detected by Investigational Imaging Agent
Time Frame: Up to approximately 2 hours to complete each scan
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.
Up to approximately 2 hours to complete each scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method
Time Frame: At 1 year post-scan 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 at the end of the 12 month standard clinical follow-up period, by comparing the investigational scans against scans the patient received as standard of care.
At 1 year post-scan follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrei Iagaru

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

February 11, 2022

Study Completion (Actual)

February 11, 2022

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-46258 (Other Identifier: Stanford IRB)
  • NCI-2018-01799 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • PROS0089 (Other Identifier: OnCore ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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