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

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

Recruiting
18 years and older
Male
Phase 2

Overview

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)

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.

Eligibility

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).

Study details
    Malignant neoplasm of prostate
    Prostatic disorder

NCT04264208

Andrei Iagaru

16 February 2024

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