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

• Sponsor: University of Alberta (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05141760
• Collaborator: Canadian Urological Association Scholarship Foundation (Other)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 34.7
• Patients Per Site Per Month: 4.3

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients
• Actual Study Start Date: Feb 10, 2022
• Anticipated Primary Completion Date: Jul 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Outcome Measures

Primary Outcome Measures

1. Tumor T-staging [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)

Secondary Outcome Measures

1. Sensitivity of PSMA-1007 PET [Through study completion, this is expected to be reviewed within 1 year of imaging]

   Compare final histology against PSMA-1007 PET

2. Sensitivity of MRI [Through study completion, this is expected to be reviewed within 1 year of imaging]

   Compare final histology against MR imaging

3. Specificity of PSMA-1007 PET [Through study completion, this is expected to be reviewed within 1 year of imaging]

   Compare final histology against PSMA-1007 PET

4. Specificity of MRI [Through study completion, this is expected to be reviewed within 1 year of imaging]

   Compare final histology against MR imaging

5. Negative Predictive Value of PSMA-1007 PET [Through study completion, this is expected to be reviewed within 1 year of imaging]

   Compare final histology against PSMA-1007 PET

6. Negative Predictive Value of MRI [Through study completion, this is expected to be reviewed within 1 year of imaging]

   Compare final histology against MR imaging

7. Positive Predictive Value of PSMA-1007 PET [Through study completion, this is expected to be reviewed within 1 year of imaging]

   Compare final histology against PSMA-1007 PET

8. Positive Predictive Value of MRI [Through study completion, this is expected to be reviewed within 1 year of imaging]

   Compare final histology against MRI

9. Nodal Staging [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

10. Metastatic Staging [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

11. Longest Tumor diameter [Through study completion, this is expected to be reviewed within 1 year of imaging]

    Compare final histology against PSMA-1007 PET and MRI measurements

12. Identification of dominant lesion [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

13. Identification of non-dominant lesion [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada	T6G 2B7

Sponsors and Collaborators

• University of Alberta
• Canadian Urological Association Scholarship Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT05141760
• Other Study ID Numbers: HREBA.CC-21-0073
• First Posted: Dec 2, 2021
• Last Update Posted: May 11, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of May 11, 2022