Prostate CancerPhase 2NCT03809078

68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

A Phase 2 study testing 68Ga RM2, 68Ga-PSMA-11 and Investigational PET scanner coils and software in people with Prostate Cancer, 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

The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Prostate Cancer
What is being tested?: 68Ga RM2, 68Ga-PSMA-11 and Investigational PET scanner coils and software
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 14 Jan 2019to 8 Mar 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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Suspected prostate cancer
Planned prostate biopsy
Able to provide written consent
Karnofsky performance status of 50 (or ECOG/WHO equivalent)

Who cannot join

Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
Metallic implants (contraindicated for MRI)

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Read the detailed description

Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Exploratory Objective:

Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy
Correlation of 68Ga RM2 and Gleason score at biopsy

Conditions: Prostate Cancer
Being tested: 68Ga RM2, 68Ga-PSMA-11, Investigational PET scanner coils and software
Keywords: Prostate Cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

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

68Ga RM2Drug
Also called 68Ga DOTA Bombesin, BAY86 7548
PET radiopharmaceutical
68Ga-PSMA-11Drug
Also called DFKZ 11, HBED CC PSMA, Heidelberg compound
PET radiopharmaceutical
Investigational PET scanner coils and softwareDevice
GE Healthcare non-approved PET scanner coils and software

Study groups in NCT03809078
Study group	Role	What they receive
68Ga RM2 first followed by 68Ga PSMA11	Experimental	Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 Receives: Drug: 68Ga RM2; Drug: 68Ga-PSMA-11; Device: Investigational PET scanner coils and software
68Ga PSMA11 first followed by 68Ga RM2	Experimental	Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 Receives: Drug: 68Ga RM2; Drug: 68Ga-PSMA-11; Device: Investigational PET scanner coils and software

What is being measured

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

Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings
Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).
Measured: Up to approximately 2 hours to complete each scan

Timeline

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

14 Jan 20198 Mar 2022

First posted18 Jan 2019
Study start14 Jan 2019
Primary completion8 Mar 2022
Study completion8 Mar 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 CancerStudies 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: Sequential
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03809078
Sponsor's protocol ID: IRB-48151
Other IDs: PROS0091, IRB-48151, NCI-2019-00236
Status last verified: Jan 2024
First submitted: 16 Jan 2019
Last updated: 11 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, Ghanouni P, Daniel B, Rosenberg J, Thong A, Kunder C, Aparici CM, Davidzon GA, Moradi F, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Biopsy Guidance in Patients with Suspected Prostate Cancer. J Nucl Med. 2023 May;64(5):744-750. doi: 10.2967/jnumed.122.264448. Epub 2022 Nov 17.
PubMed 36396456

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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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
ClinicalTrials.gov ID: NCT03809078
Acronym / sponsor ID: IRB-48151
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Andrei IagaruUniversity, hospital or other
Collaborators: General Electric
Study start: 14 Jan 2019 (actual)
Primary completion: 8 Mar 2022 (actual)
Study completion: 8 Mar 2022 (actual)
First posted: 18 Jan 2019 (actual)
Results: Posted 11 Jan 2024

Clinical summary

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

The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Detailed description

Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Exploratory Objective:

Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy
Correlation of 68Ga RM2 and Gleason score at biopsy

Study design

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

Arm	Type	Receives
68Ga RM2 first followed by 68Ga PSMA11	Experimental	Drug: 68Ga RM2, Drug: 68Ga-PSMA-11, Device: Investigational PET scanner coils and softwareParticipant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
68Ga PSMA11 first followed by 68Ga RM2	Experimental	Drug: 68Ga RM2, Drug: 68Ga-PSMA-11, Device: Investigational PET scanner coils and softwareParticipant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2

Who may qualify

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

Key inclusion criteria (4 listed)

Suspected prostate cancer
Planned prostate biopsy
Able to provide written consent
Karnofsky performance status of 50 (or ECOG/WHO equivalent)

Key exclusion criteria (2 listed)

Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
Metallic implants (contraindicated for 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
68Ga RM2Also: 68Ga DOTA Bombesin, BAY86 7548PET radiopharmaceutical	Drug	68Ga PSMA11 first followed by 68Ga RM2, 68Ga RM2 first followed by 68Ga PSMA11
68Ga-PSMA-11Also: DFKZ 11, HBED CC PSMA, Heidelberg compoundPET radiopharmaceutical	Drug	68Ga PSMA11 first followed by 68Ga RM2, 68Ga RM2 first followed by 68Ga PSMA11
Investigational PET scanner coils and softwareGE Healthcare non-approved PET scanner coils and software	Device	68Ga PSMA11 first followed by 68Ga RM2, 68Ga RM2 first followed by 68Ga PSMA11

Primary outcome

Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings
Time frame: Up to approximately 2 hours to complete each scan
Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).

Results and safety

Results posted to the registry on 11 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
68Ga PSMA11 First Followed by 68Ga RM2	7	7
68Ga RM2 First Followed by 68Ga PSMA11	7	7

Primary outcome: Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings

Time frame: Up to approximately 2 hours to complete each scan. Count of participants. Unit: Participants

Measure	68Ga PSMA11 n = 13	68Ga RM2 n = 13
Value	13	13

Population analysed: Participants who completed both scans and who had biopsy done are included in the analysis.

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
68Ga PSMA11	0 of 14 (0%)	0 of 14 (0%)	0 of 14
68Ga RM2	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36396456Duan H, Ghanouni P, Daniel B, Rosenberg J, Thong A, Kunder C, Aparici CM, Davidzon GA, Moradi F, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Biopsy Guidance in Patients with Suspected Prostate Cancer. J Nucl Med. 2023 May;64(5):744-750. doi: 10.2967/jnumed.122.264448. Epub 2022 Nov 17.
Individual participant dataSharing planned: No

Related trials for Prostate Cancer

RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
Active, not recruitingPhase 2
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions

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 H Iagaru, MD principal investigator

Stanford University

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 68Ga RM2, 68Ga-PSMA-11 and Investigational PET scanner coils and software in people with Prostate Cancer, 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 4 inclusion and 2 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 11 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 11 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 Participants With Biopsy Results Correlated With PET Based Imaging Findings (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 NCT03809078, 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 11 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.