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

Andrei Iagaru

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: 68-Ga RM2; Procedure: PET/MRI; Drug: 68-Ga PSMA11; Device: Investigational software and coils in PET/MR Scan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03949517

PROS0093 (Other Identifier)

IRB-48213 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

68-Ga RM2+68-Ga PSMA11

Experimental group

Description:

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

Treatment:

Device: Investigational software and coils in PET/MR Scan

Drug: 68-Ga PSMA11

Procedure: PET/MRI

Drug: 68-Ga RM2

68-Ga PSMA11+68-Ga RM2

Experimental group

Description:

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

Treatment:

Device: Investigational software and coils in PET/MR Scan

Drug: 68-Ga PSMA11

Procedure: PET/MRI

Drug: 68-Ga RM2