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Prostate AdenocarcinomaPhase 2/3NCT02624518

68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer

A Phase 2/3 study testing 68Ga-RM2, Magnetic Resonance Imaging and Positron Emission Tomography in people with Prostate Adenocarcinoma, 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

Prostate cancer (PC) remains the most-common non-cutaneous cancer diagnosed in American males, accounting for an estimated 174,560 estimated new cases and 31,620 estimated deaths in 2019. Up to 40% of the patients with prostate cancer develop biochemical recurrence within 10 years after initial treatment. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Adenocarcinoma
What is being tested?
68Ga-RM2, Magnetic Resonance Imaging and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteUnited States
Study dates
16 Nov 2015to Nov 2022
Phase
Phase 2/3
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 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 6-13 weeks after RP
  • Confirmatory persistent PSA greater than 0.2 ng/mL
  • Post-radiation therapy - American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition
Show all 10Show fewer
  • Nadir plus (+) greater than or equal to 2 ng/mL rise in PSA
  • No evidence of metastatic disease on conventional imaging, including a negative bone scan for skeletal metastasis and negative contrast-enhanced CT
  • Able to provide written consent
  • Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)

Who cannot join

  • Unable to provide informed consent
  • 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
  • Metallic implants

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University, School of Medicine

    Palo Alto, California, 94304

Other trials in United States

About this study

Official title: 68Ga-RM2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-contributory CT Scans

Prostate cancer (PC) remains the most-common non-cutaneous cancer diagnosed in American males, accounting for an estimated 174,560 estimated new cases and 31,620 estimated deaths in 2019. Up to 40% of the patients with prostate cancer develop biochemical recurrence within 10 years after initial treatment. Usually an increase of the prostate-specific antigen (PSA) llevel precedes a clinically detectable recurrence by months to years, and this is currently used as a screening test before and subsequent to treatment. However, disease advancement can be local, regional or systemic, and each has significantly different approaches to disease management. Unfortunately, PSA level does not differentiate between these disease stages.

This phase 2-3 study explores the utility of radiolabel 68Ga-RM2, a 68-gallium (68Ga)-labeled gastrin-releasing peptide receptor (GRPr) antagonist, for positron emission tomography (PET) / magnetic resonance imaging (MRI) (collectively, PET/MRI) as a potential tool to help discriminate between disease stages in participants after treatment with surgery or radiation, who present persistently elevated PSA levels (ie, may have prostate cancer), but were negative for cancer with a diagnostic regular medical care computed tomography (CT) scan

Read more

68Ga-RM2 (BAY86-7548) is also identified as a synthetic bombesin receptor antagonist. PET/MRI is the collective result of 2 scan processes (PET and MRI ) conducted during the same scan procedure (ie, a combined scan). After a regular medical care computed tomography (CT) scan, participants will be scanned with 68Ga-RM2 PET/MRI scan procedure. PET/MRI is used to assess the location, size, and metabolic activity of a suspected tumor.

The 68Ga-RM2 radiolabel consisted of a ligand (the synthetic bombesin receptor antagonist) and the radioisotope 68Ga. The RM2 ligand targets gastrin-releasing peptide receptors (GRPr), commonly expressed by prostate cancer cells, and the radioisotope distinguishes those cells from the background. The criteria for scan "positivity" will be, when compared to background level of the liver (control), the 68Ga signal is stronger (positive - malignant) or weaker (negative - benign).

This study will assess how well 68Ga-RM2 works in detecting prostate cancer in patients with

68Ga-RM2 PET/MRI may be able to see smaller tumors than the standard of care contrast-enhanced CT or MRI scan.

Read the detailed description

PRIMARY OBJECTIVES:

Evaluate 68Ga-RM2 as the radiolabel for PET/MRI scans used for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA) and non-contributory computed tomography (CT).

OUTLINE:

Patients receive 68Ga-RM2 intravenously (IV) and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician.

After completion of study, patients are followed up at 24 to 48 hours and then at 1 year.

Being tested
68Ga-RM2, Magnetic Resonance Imaging, Positron Emission Tomography

What participants receive

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

  • 68Ga-RM2Drug

    Also called Gallium (68Ga)-labeled gastrin-releasing peptide receptor (GRPr) antagonist, 68Ga-DOTA RM2, BAY 86-7548, 68Ga-Bombesin

    Imaging with PET/MRI

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI

    Imaging with 68Ga-RM2 PET/MRI

  • Positron Emission TomographyProcedure or surgery

    Also called PET

    Imaging with 68Ga-RM2 PET/MRI

Study groups in NCT02624518
Study groupRoleWhat they receive
Diagnostic (68Ga-RM2 PET/MRI)ExperimentalPatients receive 68Ga-RM2 IV and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. Imaging with PET/MRI is the intervention.
Receives: Drug: 68Ga-RM2; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

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

  1. Number of Tumor Lesions Detected by 68Ga-RM2 MRI vs 68Ga-RM2 PET/MRI

    Diagnostic performance of 68Ga-RM2 as a contrast imaging label will be assessed by magnetic resonance imaging (MRI) alone, or as a combined scan with positron emission tomography (PET, collectively PET/MRI). The outcome is reported as the number of tumor lesions detected with MRI alone, or with the combination PET/MRI scan, a number without dispersion.

    Measured: 1 day

  2. Sensitivity of MRI Alone vs PET/MRI

    Sensitivity is the ability of a test to correctly identify patients who have the prostate cancer, ie, how well 68Ga-RM2 MRI vs 68Ga-RM2 PET/MRI correctly detects patients who truly have prostate cancer. Sensitivity is defined as [TP/(TP+FN)], where TP=true-positive, and FN=false-negative. The outcome is a percentage number with 95% confidence interval (95% CI). A higher % value means a greater probability that an imaging target identified as cancerous is confirmed by histology to be cancerous, and a lower % means reduced confidence in that result.

    Measured: 1 day

  3. Specificity of MR Alone vs PET/MRI

    Specificity is the ability of a test to correctly identify patients who do not have the prostate cancer, ie, how well 68Ga-RM2 MRI vs 68Ga-RM2 PET/MRI correctly detects patients who do not have prostate cancer (does not falsely return a positive result). Specificity is defined as [TN/(TN+FP)], where TN=true-negative, and FP=false-positive. The outcome is a percentage number with 95% confidence interval (95% CI). A higher % value means a greater probability that an imaging target identified as non-cancerous is confirmed by histology to be non-cancerous, and a lower % means reduced confidence in that result.

    Measured: 1 day

Timeline

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

  1. First posted8 Dec 2015 (estimated)
  2. Study start16 Nov 2015
  3. Primary completion21 Jul 2021
  4. Study completionNov 2022

Resources

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 2/3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02624518
Sponsor's protocol ID
IRB-35155
Other IDs
NCI-2015-01993, PROS0074
Status last verified
Apr 2023
First submitted
30 Nov 2015
Last updated
10 Apr 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baratto L, Song H, Duan H, Hatami N, Bagshaw HP, Buyyounouski M, Hancock S, Shah S, Srinivas S, Swift P, Moradi F, Davidzon G, Iagaru A. PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2021 Nov;62(11):1545-1549. doi: 10.2967/jnumed.120.259630. Epub 2021 Mar 5.

    PubMed 33674398

  • Baratto L, Duan H, Laudicella R, Toriihara A, Hatami N, Ferri V, Iagaru A. Physiological 68Ga-RM2 uptake in patients with biochemically recurrent prostate cancer: an atlas of semi-quantitative measurements. Eur J Nucl Med Mol Imaging. 2020 Jan;47(1):115-122. doi: 10.1007/s00259-019-04503-4. Epub 2019 Sep 2.

    PubMed 31478089

  • Duan H, Moradi F, Davidzon GA, Liang T, Song H, Loening AM, Vasanawala S, Srinivas S, Brooks JD, Hancock S, Iagaru A. 68Ga-RM2 PET-MRI versus MRI alone for evaluation of patients with biochemical recurrence of prostate cancer: a single-centre, single-arm, phase 2/3 imaging trial. Lancet Oncol. 2024 Apr;25(4):501-508. doi: 10.1016/S1470-2045(24)00069-X. Epub 2024 Feb 26.

    PubMed 38423030

  • Duan H, Davidzon GA, Moradi F, Liang T, Song H, Iagaru A. Modified PROMISE criteria for standardized interpretation of gastrin-releasing peptide receptor (GRPR)-targeted PET. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):4087-4095. doi: 10.1007/s00259-023-06385-z. Epub 2023 Aug 9.

    PubMed 37555901

  • Duan H, Baratto L, Hatami N, Liang T, Levin CS, Khalighi MM, Iagaru A. Reduced Acquisition Time per Bed Position for PET/MRI Using 68Ga-RM2 or 68Ga-PSMA-11 in Patients With Prostate Cancer: A Retrospective Analysis. AJR Am J Roentgenol. 2022 Feb;218(2):333-340. doi: 10.2214/AJR.21.25961. Epub 2021 Aug 18.

    PubMed 34406051

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 68Ga-RM2, Magnetic Resonance Imaging and Positron Emission Tomography in people with Prostate Adenocarcinoma, 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 10 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 10 Apr 2023. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 Apr 2023). 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 Tumor Lesions Detected by 68Ga-RM2 MRI vs 68Ga-RM2 PET/MRI (time frame: 1 day). The study lists 3 primary outcomes in all. 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 NCT02624518, which also lists 5 linked publications.

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 10 Apr 2023.

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