Clinical trial NCT03698370: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Adenocarcinoma
PSA Progression
Recurrent Prostate Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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 \[MRI\]).

Primary outcomes:
measure: Number of Lesions Detected by Investigational Imaging Agent
timeFrame: Up to approximately 2 hours to complete each scan
Secondary outcomes:
measure: Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method
timeFrame: At 1 year post-scan follow-up
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Institute Palo Alto
state: California
Study officials:
affiliation: Stanford Cancer Institute Palo Alto
name: Andrei Iagaru
role: PRINCIPAL_INVESTIGATOR
References: