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

March 2, 2022 updated by: Andrei Iagaru

68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  1. 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.
  2. 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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-PSMA PET/MRI
Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.
Drug: 68Ga-PSMA-11
Undergo 68Ga-PSMA-11 PET/MRI
Other Names:
  • DFKZ 11
  • HBED CC PSMA
  • Heidelberg compound
  • 68-gallium prostate-specific membrane antigen 11 positron emission tomography/magnetic resonance imaging
Procedure: Magnetic resonance imaging (MRI)
Undergo 68Ga-PSMA-11 PET/MRI
Other Names:
  • NMR Imaging
  • NMRI
  • Nuclear magnetic resonance imaging
  • MRI imaging
Procedure: Positron Emission Tomography (PET)
Undergo 68Ga-PSMA-11 PET/MRI
Other Names:
  • Positron Emission Tomography Scan
  • PET scan
  • Proton magnetic resonance spectroscopic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes
Time Frame: 1 Day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes
Time Frame: 1 Day
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.
1 Day
Sensitivity of 68Ga-PSMA-11 PET/MRI
Time Frame: 1 Day
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.
1 Day
Specificity of 68Ga-PSMA-11 PET/MRI
Time Frame: 1 Day
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.
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrei Iagaru

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Andrei Iagaru, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2016

Primary Completion (Actual)

December 13, 2020

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-35931
  • NCI-2016-00092 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • PROS0075 (Other Identifier: OnCore ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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