18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients

June 4, 2024 updated by: University of Alberta

Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients

This prospective phase II study assesses the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007)) and multiparametric magnetic resonance imaging (MRI) for locoregional staging of clinically significant prostate cancer in men undergoing radical prostatectomy and bilateral pelvic lymph node dissection. The design will be a multicenter validating-paired cohort study using radical prostatectomy and pelvic lymph node dissection as the gold standard comparator. Each patient will undergo both 18F-PSMA-1007 PET and 3T MRI allowing comparison of each imaging modality within each subject. Furthermore, PET and MRI will be compared to standard-of-care imaging techniques (CT abdomen/pelvis and 99mTc-MDP Bone scan).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Adam Kinnaird, MD, PhD, FRCSC
  • Phone Number: 321 780-407-5800
  • Email: ask@ualberta.ca

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients or their legal medical decision makers will sign an informed consent prior to entering the study.
  2. Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer.
  3. Appropriate staging investigations have been performed prior to the participation in the study (i.e. CT abdomen/pelvis and 99mTc-MDP bone scan)

Exclusion Criteria:

  1. Unable to obtain consent
  2. Weight >250 kg (weight limitation of scanners)
  3. Unable to lie flat for 30 minutes to complete the PET or MRI imaging
  4. Severe claustrophobia precluding image acquisition
  5. Lack of intravenous access
  6. Non-MRI compatible pacemaker or hardware
  7. eGFR < 40 mL/min/1.73 m2 and/or a history of a severe reaction to MRI contrast
  8. Prior androgen deprivation therapy

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tumor T-staging
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b)
Through study completion, this is expected to be reviewed within 1 year of imaging

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity of PSMA-1007 PET
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare final histology against PSMA-1007 PET
Through study completion, this is expected to be reviewed within 1 year of imaging
Sensitivity of MRI
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare final histology against MR imaging
Through study completion, this is expected to be reviewed within 1 year of imaging
Specificity of PSMA-1007 PET
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare final histology against PSMA-1007 PET
Through study completion, this is expected to be reviewed within 1 year of imaging
Specificity of MRI
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare final histology against MR imaging
Through study completion, this is expected to be reviewed within 1 year of imaging
Negative Predictive Value of PSMA-1007 PET
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare final histology against PSMA-1007 PET
Through study completion, this is expected to be reviewed within 1 year of imaging
Negative Predictive Value of MRI
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare final histology against MR imaging
Through study completion, this is expected to be reviewed within 1 year of imaging
Positive Predictive Value of PSMA-1007 PET
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare final histology against PSMA-1007 PET
Through study completion, this is expected to be reviewed within 1 year of imaging
Positive Predictive Value of MRI
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare final histology against MRI
Through study completion, this is expected to be reviewed within 1 year of imaging
Nodal Staging
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Accuracy of nodal disease on PSMA-1007 PET and MRI compared to bone scan + CT
Through study completion, this is expected to be reviewed within 1 year of imaging
Metastatic Staging
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Accuracy of PSMA-1007 PET and MRI compared to bone scan + CT
Through study completion, this is expected to be reviewed within 1 year of imaging
Longest Tumor diameter
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare final histology against PSMA-1007 PET and MRI measurements
Through study completion, this is expected to be reviewed within 1 year of imaging
Identification of dominant lesion
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare rate of dominant lesion identification of PSMA-1007 PET and MRI against final histology
Through study completion, this is expected to be reviewed within 1 year of imaging
Identification of non-dominant lesion
Time Frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Compare rate of non-dominant lesion identification of PSMA-1007 PET and MRI against final histology
Through study completion, this is expected to be reviewed within 1 year of imaging

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Urological Association Scholarship Foundation

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HREBA.CC-21-0073

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

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings