NCT04264208

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Andrei Iagaru · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	68-Ga RM2.	PET radiopharmaceutical
DRUG	68-Ga PSMA11	PET radiopharmaceutical
DEVICE	PET/MRI	PET/MR scanner by GE healthcare

Timeline

• Start date: 2020-02-05
• Primary completion: 2022-11-22
• Completion: 2022-12-14
• First posted: 2020-02-11
• Last updated: 2024-02-01
• Results posted: 2024-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study