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

NCT ID: NCT05141760

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2023-06-15

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)

Additional staging PET and MRI scan prior to prostatectomy and lymph node dissection

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Urological Association Scholarship Foundation

UNKNOWN

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

HREBA.CC-21-0073

Identifier Type: -

Identifier Source: org_study_id