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

Andrei Iagaru

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Device: PET/MRI; Drug: 68-Ga RM2.; Drug: 68-Ga PSMA11

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04264208

NCI-2020-02779 (Registry Identifier)

IRB-51987

PROS0098 (Other Identifier)

1R01CA230438 (U.S. NIH Grant/Contract)

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

Full description

Primary Objective:

1. To demonstrate that 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI.
2. 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.

Enrollment: 4 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

68Ga-RM2 PET MRI then 68 Ga PMSA11 PET/MRI

Experimental group

Description:

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)

Treatment:

Device: PET/MRI

Drug: 68-Ga RM2.

Drug: 68-Ga PSMA11

68Ga-PSMA-11 PET MRI then 68Ga-RM2 PET MRI

Experimental group

Description:

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)

Treatment:

Device: PET/MRI

Drug: 68-Ga RM2.

Drug: 68-Ga PSMA11