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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05141760
• Other study ID #: HREBA.CC-21-0073
• Status: Completed
• Phase: Phase 2
• Start date: February 10, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: June 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Urological Association Scholarship Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity of PSMA-1007 PET	Compare final histology against PSMA-1007 PET	Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary	Sensitivity of MRI	Compare final histology against MR imaging	Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary	Specificity of PSMA-1007 PET	Compare final histology against PSMA-1007 PET	Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary	Specificity of MRI	Compare final histology against MR imaging	Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary	Negative Predictive Value of PSMA-1007 PET	Compare final histology against PSMA-1007 PET	Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary	Negative Predictive Value of MRI	Compare final histology against MR imaging	Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary	Positive Predictive Value of PSMA-1007 PET	Compare final histology against PSMA-1007 PET	Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary	Positive Predictive Value of MRI	Compare final histology against MRI	Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary	Nodal Staging	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
Secondary	Metastatic Staging	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
Secondary	Longest Tumor diameter	Compare final histology against PSMA-1007 PET and MRI measurements	Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary	Identification of dominant lesion	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
Secondary	Identification of non-dominant lesion	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