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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)
Sponsored by
University of Alberta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

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

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

Sites / Locations

  • University of Alberta

Outcomes

Primary Outcome Measures

Tumor T-staging
Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b)

Secondary Outcome Measures

Sensitivity of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Sensitivity of MRI
Compare final histology against MR imaging
Specificity of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Specificity of MRI
Compare final histology against MR imaging
Negative Predictive Value of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Negative Predictive Value of MRI
Compare final histology against MR imaging
Positive Predictive Value of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Positive Predictive Value of MRI
Compare final histology against MRI
Nodal Staging
Accuracy of nodal disease on PSMA-1007 PET and MRI compared to bone scan + CT
Metastatic Staging
Accuracy of PSMA-1007 PET and MRI compared to bone scan + CT
Longest Tumor diameter
Compare final histology against PSMA-1007 PET and MRI measurements
Identification of dominant lesion
Compare rate of dominant lesion identification of PSMA-1007 PET and MRI against final histology
Identification of non-dominant lesion
Compare rate of non-dominant lesion identification of PSMA-1007 PET and MRI against final histology

Full Information

First Posted
November 9, 2021
Last Updated
May 30, 2023
Sponsor
University of Alberta
Collaborators
Canadian Urological Association Scholarship Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05141760
Brief Title
18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
Official Title
Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Canadian Urological Association Scholarship Foundation

4. Oversight

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

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)
Intervention Description
Additional staging PET and MRI scan prior to prostatectomy and lymph node dissection
Primary Outcome Measure Information:
Title
Tumor T-staging
Description
Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b)
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary Outcome Measure Information:
Title
Sensitivity of PSMA-1007 PET
Description
Compare final histology against PSMA-1007 PET
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Sensitivity of MRI
Description
Compare final histology against MR imaging
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Specificity of PSMA-1007 PET
Description
Compare final histology against PSMA-1007 PET
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Specificity of MRI
Description
Compare final histology against MR imaging
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Negative Predictive Value of PSMA-1007 PET
Description
Compare final histology against PSMA-1007 PET
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Negative Predictive Value of MRI
Description
Compare final histology against MR imaging
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Positive Predictive Value of PSMA-1007 PET
Description
Compare final histology against PSMA-1007 PET
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Positive Predictive Value of MRI
Description
Compare final histology against MRI
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Nodal Staging
Description
Accuracy of nodal disease on PSMA-1007 PET and MRI compared to bone scan + CT
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Metastatic Staging
Description
Accuracy of PSMA-1007 PET and MRI compared to bone scan + CT
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Longest Tumor diameter
Description
Compare final histology against PSMA-1007 PET and MRI measurements
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Identification of dominant lesion
Description
Compare rate of dominant lesion identification of PSMA-1007 PET and MRI against final histology
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging
Title
Identification of non-dominant lesion
Description
Compare rate of non-dominant lesion identification of PSMA-1007 PET and MRI against final histology
Time Frame
Through study completion, this is expected to be reviewed within 1 year of imaging

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients or their legal medical decision makers will sign an informed consent prior to entering the study. Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer. 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: Unable to obtain consent Weight >250 kg (weight limitation of scanners) Unable to lie flat for 30 minutes to complete the PET or MRI imaging Severe claustrophobia precluding image acquisition Lack of intravenous access Non-MRI compatible pacemaker or hardware eGFR < 40 mL/min/1.73 m2 and/or a history of a severe reaction to MRI contrast Prior androgen deprivation therapy
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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