Prostate AdenocarcinomaPhase 2NCT03698370

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

A Phase 2 study testing Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 in people with Prostate Adenocarcinoma and PSA Progression, run by Andrei Iagaru at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Adenocarcinoma, PSA Progression, Recurrent Prostate Carcinoma
What is being tested?: Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 15 Dec 2020to 11 Feb 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Biopsy proven prostate adenocarcinoma.
Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation.
PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy.
Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL).
Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition.

Show all 9Show fewer

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).

Who cannot join

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]).

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304

Other trials in United States

About this study

Official title: 68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

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.

Conditions: Prostate Adenocarcinoma, PSA Progression, Recurrent Prostate Carcinoma
Being tested: Gallium Ga 68 DOTA-NeoBOMB1, Gallium Ga 68 PSMA-R2
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gallium Ga 68 DOTA-NeoBOMB1Drug
Also called Ga68-NeoBOMB1
Administered intravenously (IV)
Gallium Ga 68 PSMA-R2Device
Also called Ga68 PSMA-R2
Administered intravenously (IV)

Study groups in NCT03698370
Study group	Role	What they receive
Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2	Experimental	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. Receives: Drug: Gallium Ga 68 DOTA-NeoBOMB1; Device: Gallium Ga 68 PSMA-R2
Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)	Experimental	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. Receives: Drug: Gallium Ga 68 DOTA-NeoBOMB1; Device: Gallium Ga 68 PSMA-R2

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to approximately 2 hours to complete each scan

Secondary outcomes (1)

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.
Measured: At 1 year post-scan follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202011 Feb 2022

First posted9 Oct 2018
Study start15 Dec 2020
Primary completion11 Feb 2022
Study completion11 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03698370
Sponsor's protocol ID: IRB-46258
Other IDs: NCI-2018-01799, IRB-46258, PROS0089
Status last verified: Jan 2024
First submitted: 4 Oct 2018
Last updated: 30 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Duan H, Song H, Davidzon GA, Moradi F, Liang T, Loening A, Vasanawala S, Iagaru A. Prospective Comparison of 68Ga-NeoB and 68Ga-PSMA-R2 PET/MRI in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2024 Jun 3;65(6):897-903. doi: 10.2967/jnumed.123.267017.
PubMed 38664016

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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The Vanguard Study: Testing a New Way to Screen for Cancer
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All Prostate Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer
ClinicalTrials.gov ID: NCT03698370
Acronym / sponsor ID: IRB-46258
Conditions: Prostate Adenocarcinoma, PSA Progression, Recurrent Prostate Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Andrei IagaruUniversity, hospital or other
Study start: 15 Dec 2020 (actual)
Primary completion: 11 Feb 2022 (actual)
Study completion: 11 Feb 2022 (actual)
First posted: 9 Oct 2018 (actual)
Results: Posted 30 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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.

After completion of study, participants are followed up at 12 months.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2	Experimental	Drug: Gallium Ga 68 DOTA-NeoBOMB1, Device: Gallium Ga 68 PSMA-R2Participants 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.
Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)	Experimental	Drug: Gallium Ga 68 DOTA-NeoBOMB1, Device: Gallium Ga 68 PSMA-R2Participants 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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Biopsy proven prostate adenocarcinoma.
Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL).
Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition.
A rise of PSA measurement of 2 or more ng/mL over the nadir.

Key exclusion criteria (5 listed)

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]).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gallium Ga 68 DOTA-NeoBOMB1Also: Ga68-NeoBOMB1Administered intravenously (IV)	Drug	Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2, Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)
Gallium Ga 68 PSMA-R2Also: Ga68 PSMA-R2Administered intravenously (IV)	Device	Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2, Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)

Primary outcome

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.

1 secondary outcome

Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method
Time frame: At 1 year post-scan follow-up

Results and safety

Results posted to the registry on 30 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ga68-NeoBOMB1 Then Ga68 PSMA-R2	13	13
Ga68 PSMA-R2 Then Ga 68-NeoBOMB1)	14	14

Primary outcome: Number of Lesions Detected by Investigational Imaging Agent

Time frame: Up to approximately 2 hours to complete each scan. Number. Unit: lesions

Measure	Ga68-NeoBOMB1 n = 27	Ga68 PSMA-R2 n = 27
Value	31	20

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 weeks, plus safety follow up at to 72 hours after the final scan. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ga68-NeoBOMB1	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Ga68 PSMA-R2	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38664016Duan H, Song H, Davidzon GA, Moradi F, Liang T, Loening A, Vasanawala S, Iagaru A. Prospective Comparison of 68Ga-NeoB and 68Ga-PSMA-R2 PET/MRI in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2024 Jun 3;65(6):897-903. doi: 10.2967/jnumed.123.267017.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrei Iagaru principal investigator

Stanford Cancer Institute Palo Alto

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 in people with Prostate Adenocarcinoma and PSA Progression, run by Andrei Iagaru at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Lesions Detected by Investigational Imaging Agent (time frame: Up to approximately 2 hours to complete each scan). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03698370, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.