68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery
68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer
3 other identifiers
interventional
74
1 country
1
Brief Summary
This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2016
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
February 2, 2016
CompletedFirst Posted
Study publicly available on registry
February 9, 2016
CompletedStudy Start
First participant enrolled
April 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedResults Posted
Study results publicly available
March 4, 2022
CompletedMarch 4, 2022
March 1, 2022
4.7 years
February 2, 2016
January 6, 2022
March 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes
68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as assessed by imaging interpretation. The outcome will be expressed as the number of participants with metastatic disease, as identified by PET/MRI, a number without dispersion.
1 Day
Secondary Outcomes (3)
Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes
1 Day
Sensitivity of 68Ga-PSMA-11 PET/MRI
1 Day
Specificity of 68Ga-PSMA-11 PET/MRI
1 Day
Study Arms (1)
68Ga-PSMA PET/MRI
EXPERIMENTALPatients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.
Interventions
Undergo 68Ga-PSMA-11 PET/MRI
Undergo 68Ga-PSMA-11 PET/MRI
Undergo 68Ga-PSMA-11 PET/MRI
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 prostate-specific antigen (PSA) \[PSA \> 10\], T stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
- Karnofsky performance status of ≥ 50 \[or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent\]
- Diagnostic CT or MRI performed within 90 days of the research PET
- Able to provide written consent
You may not qualify if:
- Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu)
- Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery
- Metallic implants (contraindicated for MRI)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrei Iagarulead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Stanford University, School of Medicine
Palo Alto, California, 94304, United States
Related Publications (1)
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: 34406051DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrea Otte
- Organization
- Stanford Medicine at Stanford University
Study Officials
- PRINCIPAL INVESTIGATOR
Andrei Iagaru
Stanford University
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
- Associate Professor of Radiology
Study Record Dates
First Submitted
February 2, 2016
First Posted
February 9, 2016
Study Start
April 18, 2016
Primary Completion
December 13, 2020
Study Completion
December 1, 2021
Last Updated
March 4, 2022
Results First Posted
March 4, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share