68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer
68Ga-RM2 PET/CT for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer
3 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2017
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2017
CompletedStudy Start
First participant enrolled
April 10, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2021
CompletedResults Posted
Study results publicly available
May 24, 2023
CompletedDecember 12, 2023
November 1, 2023
4.7 years
April 10, 2017
April 18, 2023
November 18, 2023
Conditions
Outcome Measures
Primary Outcomes (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
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 prostatectomy
week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess
Secondary Outcomes (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
week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess
Other Outcomes (3)
Incidence of Osseous and Distant Metastatic Lesions
Up to 3 years
Maximum Standardized Uptake Value (SUVmax) From 68Ga-RM2 PET
Up to 3 years
PSA Progression Free Survival
At 1 year
Study Arms (1)
Diagnostic (68Ga-RM2 PET/CT)
EXPERIMENTALPatients 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.
Interventions
Undergo PET/CT
Given IV
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrei Iagarulead
Study Sites (1)
Stanford University, School of Medicine
Palo Alto, California, 94304, United States
Related Publications (1)
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: 37555901DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David G Marcellus
- Organization
- Stanford Medicine at Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Andrei Iagaru
Stanford Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
- 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
- Associate Professor of Radiology
Study Record Dates
First Submitted
April 10, 2017
First Posted
April 13, 2017
Study Start
April 10, 2017
Primary Completion
December 19, 2021
Study Completion
December 19, 2021
Last Updated
December 12, 2023
Results First Posted
May 24, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share