68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Gallium Ga 68 DOTA-NeoBOMB1
- Conditions
- Prostate Adenocarcinoma
- Sponsor
- Andrei Iagaru
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Number of Lesions Detected by Investigational Imaging Agent
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Stanford University
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 \[MRI\]).
Arms & Interventions
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.
Intervention: Gallium Ga 68 DOTA-NeoBOMB1
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.
Intervention: Gallium Ga 68 PSMA-R2
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.
Intervention: Gallium Ga 68 DOTA-NeoBOMB1
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.
Intervention: Gallium Ga 68 PSMA-R2
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method(At 1 year post-scan follow-up)