A Pilot Study of 68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU or HDR Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of 68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU or HDR Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 68-Ga RM2
* Drug: 68-Ga PSMA11
* Device: Investigational software and coils in PET/MR Scan
* Procedure: PET/MRI


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68-Ga RM2+68-Ga PSMA11<br>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 | Drug: 68-Ga RM2<br>* Radioactive agent<br>* Other names: BAY86-7548;Drug: 68-Ga PSMA11<br>* Radioactive agent<br>* Other names: Heidelberg compound;Device: Investigational software and coils in PET/MR Scan<br>* Investigational software and coils in PET/MR Scan by General Electric Healthcare<br>Procedure: PET/MRI<br>* Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan<br>* Other names: Positron emission tomography (PET)/Magnetic resonance imaging (MRI);|
| Experimental: 68-Ga PSMA11+68-Ga RM2<br>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 | Drug: 68-Ga RM2<br>* Radioactive agent<br>* Other names: BAY86-7548;Drug: 68-Ga PSMA11<br>* Radioactive agent<br>* Other names: Heidelberg compound;Device: Investigational software and coils in PET/MR Scan<br>* Investigational software and coils in PET/MR Scan by General Electric Healthcare<br>Procedure: PET/MRI<br>* Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan<br>* Other names: Positron emission tomography (PET)/Magnetic resonance imaging (MRI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron emission tomography (PET) based of Assessment of Local Therapeutic Response | Therapeutic response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans. The outcome is the number of participants without dispersion, by randomization schedule, for which an assessment of PET based therapeutic response to HIFU or HDR is successfully obtained. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer