68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: 68Ga RM2; Drug: 68Ga-PSMA-11; Device: Investigational PET scanner coils and software

• Registration Number: NCT03809078
• Lead Sponsor: Andrei Iagaru

Brief Summary

The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Detailed Description

Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Exploratory Objective:

* Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy

* Correlation of 68Ga RM2 and Gleason score at biopsy

Study Timeline

• Study Start: 2019-01-14
• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-08
• Results First Submitted: 2023-12-01
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Results First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Suspected prostate cancer
• Planned prostate biopsy
• Able to provide written consent
• Karnofsky performance status of 50 (or ECOG/WHO equivalent)

Exclusion Criteria

• Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
• Metallic implants (contraindicated for MRI)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
68Ga RM2 first followed by 68Ga PSMA11	Investigational PET scanner coils and software	Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
68Ga PSMA11 first followed by 68Ga RM2	68Ga RM2	Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
68Ga RM2 first followed by 68Ga PSMA11	68Ga RM2	Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
68Ga PSMA11 first followed by 68Ga RM2	68Ga-PSMA-11	Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
68Ga PSMA11 first followed by 68Ga RM2	Investigational PET scanner coils and software	Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
68Ga RM2 first followed by 68Ga PSMA11	68Ga-PSMA-11	Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11

Primary Outcome Measures

Name	Time	Method
Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings	Up to approximately 2 hours to complete each scan	Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States