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

Andrei Iagaru

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Device: Investigational PET scanner coils and software; Drug: 68Ga RM2; Drug: 68Ga-PSMA-11

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03809078

IRB-48151 (Other Identifier)

PROS0091 (Other Identifier)

NCI-2019-00236 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

68Ga RM2 first followed by 68Ga PSMA11

Experimental group

Description:

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

Treatment:

Drug: 68Ga-PSMA-11

Device: Investigational PET scanner coils and software

Drug: 68Ga RM2

68Ga PSMA11 first followed by 68Ga RM2

Experimental group

Description:

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

Treatment:

Drug: 68Ga-PSMA-11

Device: Investigational PET scanner coils and software

Drug: 68Ga RM2