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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2027
  • participants needed
    100
  • sponsor
    Andrei Iagaru
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Updated on 19 February 2024
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brachytherapy
local therapy
pet/mri

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)

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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder
Age 18-100 years
Treatment 68-Ga RM2., 68-Ga PSMA11, PET/MRI
Clinical Study IdentifierNCT04264208
SponsorAndrei Iagaru
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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