Prostate Adenocarcinoma, PSA Progression, Recurrent Prostate Carcinoma
Conditions
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.
Interventions
DRUGGallium Ga 68 DOTA-NeoBOMB1
Administered intravenously (IV)
DEVICEGallium Ga 68 PSMA-R2
Administered intravenously (IV)
Sponsors
Andrei Iagaru
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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 \[MRI\]).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions Detected by Investigational Imaging Agent | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ga68-NeoBOMB1 Then 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. | 13 |
| Ga68 PSMA-R2 Then 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. | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Ga68-NeoBOMB1 Then Ga68 PSMA-R2 | Total | Ga68 PSMA-R2 Then Ga 68-NeoBOMB1) |
|---|---|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 8.1 | 67.8 years STANDARD_DEVIATION 8.8 | 67.9 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 25 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 23 Participants | 12 Participants |
| Region of Enrollment United States | 13 Participants | 27 Participants | 14 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 27 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
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.
Time frame: Up to approximately 2 hours to complete each scan
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ga68-NeoBOMB1 | Number of Lesions Detected by Investigational Imaging Agent | 31 lesions |
| Ga68 PSMA-R2 | Number of Lesions Detected by Investigational Imaging Agent | 20 lesions |
Secondary
Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method
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.
Time frame: At 1 year post-scan follow-up
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Ga68-NeoBOMB1 | Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method | 18 lesions |
| Ga68 PSMA-R2 | Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method | 15 lesions |