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

Study Overview
=================
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

Official Title
-----------------
A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: 68Ga RM2
* Drug: 68Ga-PSMA-11
* Device: Investigational PET scanner coils and software


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga RM2 first followed by 68Ga PSMA11<br>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 | Drug: 68Ga RM2<br>* PET radiopharmaceutical<br>* Other names: BAY86 7548;Drug: 68Ga-PSMA-11<br>* PET radiopharmaceutical<br>* Other names: Heidelberg compound;Device: Investigational PET scanner coils and software<br>* GE Healthcare non-approved PET scanner coils and software<br>|
| Experimental: 68Ga PSMA11 first followed by 68Ga RM2<br>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 | Drug: 68Ga RM2<br>* PET radiopharmaceutical<br>* Other names: BAY86 7548;Drug: 68Ga-PSMA-11<br>* PET radiopharmaceutical<br>* Other names: Heidelberg compound;Device: Investigational PET scanner coils and software<br>* GE Healthcare non-approved PET scanner coils and software<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET based Biopsy Guidance | PET based Biopsy Guidance will be assessed as number of participants with biopsy results correlated with imaging findings (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans). The outcome will be reported as the number of participants without dispersion for which PET based biopsy guidance is successfully obtained. | 12 months | 

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