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

NCT05141760 | Completed Phase 2 DMC

• 1 other identifier: HREBA.CC-21-0073
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Tumor T-staging

  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 Outcomes (13)

• Sensitivity of PSMA-1007 PET

  Through study completion, this is expected to be reviewed within 1 year of imaging

• Sensitivity of MRI

  Through study completion, this is expected to be reviewed within 1 year of imaging

• Specificity of PSMA-1007 PET

  Through study completion, this is expected to be reviewed within 1 year of imaging

• Specificity of MRI

  Through study completion, this is expected to be reviewed within 1 year of imaging

• Negative Predictive Value of PSMA-1007 PET

  Through study completion, this is expected to be reviewed within 1 year of imaging

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Urological Association Scholarship Foundation: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radionuclide Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 2, 2021
• Study Start: February 10, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)