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68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03113617
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Brief Summary:
This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed tomography (CT) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller tumors than the standard of care CT or magnetic resonance imaging scan.

Condition or disease Intervention/treatment Phase
Stage II Prostate Adenocarcinoma Stage III Prostate Adenocarcinoma Stage IV Prostate Adenocarcinoma Procedure: Computed Tomography Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548 Other: Laboratory Biomarker Analysis Procedure: Positron Emission Tomography Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-RM2 PET/CT for detection of intermediate and high-risk prostate cancer prior to prostatectomy.

OUTLINE:

Patients receive 68Ga-RM2 intravenously (IV). Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.

After completion of study, patients are followed up at 24-48 hours and within 3-12 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-RM2 PET/CT for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : April 10, 2020
Estimated Study Completion Date : April 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Diagnostic (68Ga-RM2 PET/CT)
Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
Drug: Gallium Ga 68-labeled GRPR Antagonist BAY86-7548
Given IV
Other Names:
  • (68)Ga-DOTA-4-amino-1-carboxymethylpiperidine-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2
  • 68Ga-Bombesin Antagonist BAY86-7548
  • 68Ga-DOTA RM2
  • 68Ga-DOTA-Bombesin Analog BAY86-7548
  • [68Ga]-labeled Bombesin Analog BAY86-7548
  • [68Ga]RM2
  • BAY 86-7548
  • Ga-68-labeled Bombesin Antagonist BAY 86-7548
  • Gallium Ga68-labeled GRPR Antagonist RM2
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging



Primary Outcome Measures :
  1. Sensitivity, specificity, positive, and negative predictive value of 68Ga-RM2 PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy [ Time Frame: Up to 3 years ]
    True positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after pr


Secondary Outcome Measures :
  1. Sensitivity, specificity, negative and positive predictive value for detection of regional nodal metastases in comparison to cross sectional imaging performed contemporaneously with the 68Ga-RM2 PET [ Time Frame: Up to 3 years ]
    True positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after pr


Other Outcome Measures:
  1. Incidence of osseous and distant metastatic lesions [ Time Frame: Up to 3 years ]
  2. Maximum standardized uptake value (SUVmax) from 68Ga-RM2 PET [ Time Frame: Up to 3 years ]
    Correlation between SUVmax from gallium Ga 68-labeled GRPR antagonist BAY86-7548 PET and short axis diameter of nodal disease on cross sectional imaging correlate to presence of true pathology will be performed.

  3. PSA progression free survival [ Time Frame: At 1 year ]
    Patients with and without pelvic nodal metastases will be compared.



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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven prostate adenocarcinoma
  • Planned prostatectomy with lymph node dissection
  • Intermediate to high-risk disease (as determined by elevated PSA [PSA > 10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
  • Able to provide written consent
  • Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
  • Diagnostic CT or magnetic resonance imaging (MRI) performed within 30 days prior to the 68Ga-RM2 PET

Exclusion Criteria:

  • Inability to lie still for the entire imaging time (approximately 30 minutes)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113617


Locations
United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Jordan Cisneros    650-725-6409    jordan.cisneros@stanford.edu   
Principal Investigator: Andrei Iagaru         
Sponsors and Collaborators
Andrei Iagaru
Investigators
Principal Investigator: Andrei Iagaru Stanford Cancer Institute

Responsible Party: Andrei Iagaru, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT03113617     History of Changes
Other Study ID Numbers: PROS0077
NCI-2017-00547 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PROS0077 ( Other Identifier: Stanford Cancer Institute )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bombesin
Gastrin-Releasing Peptide
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents