HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer

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 dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer (PC)

Detailed Description
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Primary Objective: To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment and predict progression free survival (PFS) at 24 months.

Official Title
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Evaluation of Patients With Low-Risk and Intermediate-Risk Prostate Cancer Scheduled for High-Dose Rate Brachytherapy Using 68-Ga-RM2 PET, 68Ga-PSMA-11 PET and Multi Parametric MRI

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 68-Ga RM2.
* Drug: 68-Ga PSMA11
* Device: PET/MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be at least 18 years of age; Patients must be able to provide informed consent; Histologically proven low-grade or intermediate-grade prostate cancer (PC) Scheduled to undergo targeted local therapy (HDR brachytherapy). Exclusion Criteria: Inability to lie still for the entire imaging time; Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.); Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance; 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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Male

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: 68Ga-RM2 PET MRI/68Ga PMSA11 PET/MRI<br>Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi) | Drug: 68-Ga RM2.<br>* PET radiopharmaceutical<br>* Other names: 68Ga DOTA Bombesin;Drug: 68-Ga PSMA11<br>* PET radiopharmaceutical<br>* Other names: Heidelberg compound;Device: PET/MRI<br>* PET/MR scanner by GE healthcare<br>* Other names: PET/MR scanner;|
| Experimental: 68Ga-PSMA-11 PET MRI/68Ga-RM2 PET MRI<br>Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi) | Drug: 68-Ga RM2.<br>* PET radiopharmaceutical<br>* Other names: 68Ga DOTA Bombesin;Drug: 68-Ga PSMA11<br>* PET radiopharmaceutical<br>* Other names: Heidelberg compound;Device: PET/MRI<br>* PET/MR scanner by GE healthcare<br>* Other names: PET/MR scanner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 68-Ga-RM2 and 68-Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI | Detection of PC lesions will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. The outcome is the number of participants without dispersion, by randomization schedule, for which an assessment of PET based PC lesions is successfully obtained. | 60 months | 
| 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment | Therapeutic response to HDR will be assessed by 68Ga PSMA 11 and 68Ga 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 HDR is successfully obtained. | 84 months | 
| Progression free survival (PFS) | Progression-free survival (PFS) will be assessed as survival without progression at 24 months. The outcome is reported as the number (without dispersion) of the participants alive without progression. | 24 months |