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68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

Primary Purpose

Stage II Prostate Adenocarcinoma, Stage III Prostate Adenocarcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68Ga-PSMA-11
Magnetic resonance imaging (MRI)
Positron Emission Tomography (PET)
Sponsored by
Andrei Iagaru
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage II Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

INCLUSION CRITERIA

  • 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

ExCLUSION CRITERIA

  • 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)

Sites / Locations

  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-PSMA PET/MRI

Arm Description

Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes
Participants that undergo prostatectomy will be evaluated for prostate cancer metastasis to the lymph nodes as determined by histopathology. Each participants will be interpreted as either positive or negative for the presence of metastatic disease by histopathology. The outcome will be expressed as the number of participants with metastatic disease, as identified by histopathology, a number without dispersion.
Sensitivity of 68Ga-PSMA-11 PET/MRI
68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), sensitivity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, sensitivity means the 2 assessments are in agreement that the participant truly has (ie, true-positive) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is detected (true-positive), a number without dispersion.
Specificity of 68Ga-PSMA-11 PET/MRI
68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), specificity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, specificity means the 2 assessments are in agreement that the participant does not (ie, true-negative) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is not detected (true-negative), a number without dispersion.

Full Information

First Posted
February 2, 2016
Last Updated
March 2, 2022
Sponsor
Andrei Iagaru
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02678351
Brief Title
68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery
Official Title
68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 18, 2016 (Actual)
Primary Completion Date
December 13, 2020 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrei Iagaru
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: To evaluate 68Ga-PSMA-11 PET/MRI for detection of tumor metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. To assess sensitivity (positive predictive value) and specificity (negative predictive value) of 68Ga-PSMA-11 PET/MRI for the detection of regional nodal metastases compared to pathology at radical prostatectomy. OUTLINE: Participants will receive 68Ga-PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection. After completion of study, patients are followed up at 24 to 48 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II Prostate Adenocarcinoma, Stage III Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
68Ga-PSMA PET/MRI
Arm Type
Experimental
Arm Description
Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.
Intervention Type
Drug
Intervention Name(s)
68Ga-PSMA-11
Other Intervention Name(s)
68-gallium prostate-specific membrane antigen 11 positron emission tomography/magnetic resonance imaging, HBED CC PSMA, DFKZ 11, Heidelberg compound
Intervention Description
Undergo 68Ga-PSMA-11 PET/MRI
Intervention Type
Procedure
Intervention Name(s)
Magnetic resonance imaging (MRI)
Other Intervention Name(s)
Nuclear magnetic resonance imaging, MRI imaging, NMR Imaging, NMRI
Intervention Description
Undergo 68Ga-PSMA-11 PET/MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET)
Other Intervention Name(s)
PET scan, Positron Emission Tomography Scan, Proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo 68Ga-PSMA-11 PET/MRI
Primary Outcome Measure Information:
Title
68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes
Description
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.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes
Description
Participants that undergo prostatectomy will be evaluated for prostate cancer metastasis to the lymph nodes as determined by histopathology. Each participants will be interpreted as either positive or negative for the presence of metastatic disease by histopathology. The outcome will be expressed as the number of participants with metastatic disease, as identified by histopathology, a number without dispersion.
Time Frame
1 Day
Title
Sensitivity of 68Ga-PSMA-11 PET/MRI
Description
68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), sensitivity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, sensitivity means the 2 assessments are in agreement that the participant truly has (ie, true-positive) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is detected (true-positive), a number without dispersion.
Time Frame
1 Day
Title
Specificity of 68Ga-PSMA-11 PET/MRI
Description
68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), specificity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, specificity means the 2 assessments are in agreement that the participant does not (ie, true-negative) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is not detected (true-negative), a number without dispersion.
Time Frame
1 Day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA 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 ExCLUSION CRITERIA 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Iagaru
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34406051
Citation
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.
Results Reference
derived

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68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

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