68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: 68-Ga RM2; Drug: 68-Ga PSMA11; Device: Investigational software and coils in PET/MR Scan; Procedure: PET/MRI

• Registration Number: NCT03949517
• Lead Sponsor: Andrei Iagaru

Brief Summary

This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.

Detailed Description

Primary Objective: To determine feasibility of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for evaluation of HIFU or HDR local therapy in patients with known prostate cancer.

Study Timeline

• Study Start: 2019-04-09
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-14
• Primary Completion: 2022-03-07
• Study Completion: 2022-03-07
• Results First Submitted: 2023-12-01
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Results First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

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

Inclusion Criteria

• Known prostate cancer
• Planned HIFU or HDR local therapy
• Able to provide written consent
• Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (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: PARALLEL

Arm && Interventions

Group	Intervention	Description
68-Ga RM2+68-Ga PSMA11	Investigational software and coils in PET/MR Scan	68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
68-Ga PSMA11+68-Ga RM2	68-Ga RM2	68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
68-Ga RM2+68-Ga PSMA11	68-Ga RM2	68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
68-Ga PSMA11+68-Ga RM2	68-Ga PSMA11	68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
68-Ga RM2+68-Ga PSMA11	68-Ga PSMA11	68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
68-Ga RM2+68-Ga PSMA11	PET/MRI	68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
68-Ga PSMA11+68-Ga RM2	PET/MRI	68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
68-Ga PSMA11+68-Ga RM2	Investigational software and coils in PET/MR Scan	68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11

Primary Outcome Measures

Name	Time	Method
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained	Up to approximately 2 hours to complete each scan	Positron emission tomography (PET) based of Assessment of Local Therapeutic Response. Therapeutic response to HIFU will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States