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

NCT02624518 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-35155NCI-2015-01993PROS0074
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• 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.

  1 day

• 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.

  1 day

• 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.

  1 day

Study Arms (1)

Diagnostic (68Ga-RM2 PET/MRI)

EXPERIMENTAL

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.

Drug: 68Ga-RM2; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Interventions

68Ga-RM2 DRUG

Imaging with PET/MRI

Also known as: Gallium (68Ga)-labeled gastrin-releasing peptide receptor (GRPr) antagonist, 68Ga-DOTA RM2, BAY 86-7548, 68Ga-Bombesin, DOT-bombesin

Diagnostic (68Ga-RM2 PET/MRI)

Magnetic Resonance Imaging PROCEDURE

Imaging with 68Ga-RM2 PET/MRI

Also known as: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI

Diagnostic (68Ga-RM2 PET/MRI)

Positron Emission Tomography PROCEDURE

Imaging with 68Ga-RM2 PET/MRI

Also known as: PET

Diagnostic (68Ga-RM2 PET/MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrei Iagaru: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

Related Publications (5)

• 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.

  PMID: 33674398 BACKGROUND

• 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.

  PMID: 31478089 RESULT

• 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.

  PMID: 38423030 DERIVED

• 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.

  PMID: 37555901 DERIVED

• 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.

  PMID: 34406051 DERIVED

MeSH Terms

Interventions

BAY 86-7548; Gallium; Receptors, Bombesin; 68Ga-bombesin; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Neuropeptide; Receptors, Neurotransmitter; Receptors, Peptide; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: David G Marcellus
• Organization: Stanford Medicine at Stanford University

dmarcel2@stanford.edu

650-723-4547

Study Officials

• Andrei Iagaru

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 8, 2015
• Study Start: November 16, 2015
• Primary Completion: July 21, 2021
• Study Completion: November 1, 2022
• Last Updated: April 10, 2023
• Results First Posted: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)