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

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.

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]).