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

NCT ID: NCT02624518

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-16
• Study Completion Date: 2022-11-30

Brief 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. 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

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.

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.

Conditions

Prostate Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (68Ga-RM2 PET/MRI)

Patients 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.

Group Type: EXPERIMENTAL

68Ga-RM2

Intervention Type: DRUG

Imaging with PET/MRI

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Imaging with 68Ga-RM2 PET/MRI

Positron Emission Tomography

Intervention Type: PROCEDURE

Imaging with 68Ga-RM2 PET/MRI

Interventions

68Ga-RM2

Imaging with PET/MRI

Intervention Type: DRUG

Magnetic Resonance Imaging

Imaging with 68Ga-RM2 PET/MRI

Intervention Type: PROCEDURE

Positron Emission Tomography

Imaging with 68Ga-RM2 PET/MRI

Intervention Type: PROCEDURE

Other Intervention Names

Gallium (68Ga)-labeled gastrin-releasing peptide receptor (GRPr) antagonist; 68Ga-DOTA RM2; BAY 86-7548; 68Ga-Bombesin; DOT-bombesin; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MRI; PET

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Andrei Iagaru

OTHER

Sponsor Role: lead

Responsible Party

Andrei Iagaru

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrei Iagaru

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 33674398 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31478089 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38423030 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37555901 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34406051 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2015-01993

Identifier Type: OTHER

Identifier Source: secondary_id

PROS0074

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-35155

Identifier Type: -

Identifier Source: org_study_id