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

Primary Purpose

Prostate Adenocarcinoma, PSA Progression, Recurrent Prostate Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gallium Ga 68 DOTA-NeoBOMB1
Gallium Ga 68 PSMA-R2
Sponsored by
Andrei Iagaru
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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]).

Sites / Locations

  • Stanford Cancer Institute Palo Alto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2

Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of lesions detected by investigational imaging agent
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

Predictive value of malignancy
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.

Full Information

First Posted
October 4, 2018
Last Updated
May 24, 2023
Sponsor
Andrei Iagaru
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1. Study Identification

Unique Protocol Identification Number
NCT03698370
Brief Title
Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer
Official Title
68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrei Iagaru

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, PSA Progression, Recurrent Prostate Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gallium Ga 68 DOTA-NeoBOMB1
Other Intervention Name(s)
Ga68-NeoBOMB1
Intervention Description
Administered intravenously (IV)
Intervention Type
Device
Intervention Name(s)
Gallium Ga 68 PSMA-R2
Other Intervention Name(s)
Ga68 PSMA-R2
Intervention Description
Administered intravenously (IV)
Primary Outcome Measure Information:
Title
Number of lesions detected by investigational imaging agent
Description
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.
Time Frame
Within 30 days of imaging
Secondary Outcome Measure Information:
Title
Predictive value of malignancy
Description
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.
Time Frame
After 1 year clinical follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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]).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Iagaru
Organizational Affiliation
Stanford Cancer Institute Palo Alto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Institute Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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