A Phase 2 interventional study of Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 in Prostate Adenocarcinoma, PSA Progression and Recurrent Prostate Carcinoma, sponsored by Andrei Iagaru. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Andrei Iagaru · Phase 2, Interventional, and Diagnostic
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Andrei Iagaru is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Gallium Ga 68 DOTA-NeoBOMB1 · Device: Gallium Ga 68 PSMA-R2
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.
Drug: Gallium Ga 68 DOTA-NeoBOMB1 · Device: Gallium Ga 68 PSMA-R2
Administered intravenously (IV)
Also known as: Ga68-NeoBOMB1
Administered intravenously (IV)
Also known as: Ga68 PSMA-R2
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
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
| Milestone | Ga68-NeoBOMB1 Then Ga68 PSMA-R2 | Ga68 PSMA-R2 Then Ga 68-NeoBOMB1) |
|---|---|---|
| Started | 13 | 14 |
| Completed | 13 | 14 |
| Not completed | 0 | 0 |
| Milestone | Ga68-NeoBOMB1 Then Ga68 PSMA-R2 | Ga68 PSMA-R2 Then Ga 68-NeoBOMB1) |
|---|---|---|
| Started | 13 | 14 |
| Completed | 13 | 14 |
| Not completed | 0 | 0 |
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.
| lesions | Ga68-NeoBOMB1 | Ga68 PSMA-R2 |
|---|---|---|
| Number of Lesions Detected by Investigational Imaging Agent | 31 | 20 |
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.
| lesions | Ga68-NeoBOMB1 | Ga68 PSMA-R2 |
|---|---|---|
| Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method | 18 | 15 |
Collected over 2 weeks, plus safety follow up at to 72 hours after the final scan. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ga68-NeoBOMB1 | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Ga68 PSMA-R2 | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Age, Continuous(years) | Ga68-NeoBOMB1 Then Ga68 PSMA-R2 | Ga68 PSMA-R2 Then Ga 68-NeoBOMB1) | Total |
|---|---|---|---|
| Mean | 67.8 ± 8.1 | 67.9 ± 9.4 | 67.8 ± 8.8 |
| Sex: Female, Male(Participants) | Ga68-NeoBOMB1 Then Ga68 PSMA-R2 | Ga68 PSMA-R2 Then Ga 68-NeoBOMB1) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 13 | 14 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Ga68-NeoBOMB1 Then Ga68 PSMA-R2 | Ga68 PSMA-R2 Then Ga 68-NeoBOMB1) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 11 | 14 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ga68-NeoBOMB1 Then Ga68 PSMA-R2 | Ga68 PSMA-R2 Then Ga 68-NeoBOMB1) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 11 | 12 | 23 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Ga68-NeoBOMB1 Then Ga68 PSMA-R2 | Ga68 PSMA-R2 Then Ga 68-NeoBOMB1) | Total |
|---|---|---|---|
| United States | 13 | 14 | 27 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Feb 2022, 13 months.
Results were first posted in Jan 2024, 1 year 11 months after primary completion.
Of 610 non-industry phase 2 interventional studies under Prostatic Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 86. This study's 13 months is below that.
Counting every sponsor, half of 724 studies reached it within 53 months; a quarter within 34 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Andrei Iagaru