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Enrolling by Invitation

NCT Number: NCT07132073

MRI-guided Locoregional SBRT Prostate Program

The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Prostate Cancer Program will allow to reproduce the results obtained with state-of-the-art brachytherapy combined with EBRT with the added advantage of convenience.

Enrolling by Invitation

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Universidad de Navarra Cancer Center

Pamplona, Foral Community of Navarre, 31008, Spain

About this study

The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Prostate Cancer Program will allow to reproduce the results obtained with state-of-the-art brachytherapy combined with EBRT with the added advantage of convenience.

Rationale In the radiation setting, MRI provides superior soft tissue contrast compared to standard onboard X-ray imaging improving inter- and intra- observer delineation variation. MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen. This is especially important in prostate cancer where the prostate is subject to large intra and/or interfractional position changes due to rectal and bladder filling changes.

Primary Objectives A. To achieve a 5-year biochemical relapse-free survival of 85%. B. To decrease urinary grade 3 or greater toxicity below 5% and rectal grade 3 or greater toxicity below 2%.

Secondary Objectives A. Determination of blood and urine biomarkers of treatment response and toxicity .

B. Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of QOL with IPSS and EORTC QLQ-PR25

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with unfavorable intermediate, high and very high risk PCa as per the NCCN stratification criteria .
  • Suboptimal candidates for high-dose therapy such as elderly, frail patients or patients with large volume glands (i.e, >60cm3) or extensive TURP in the prior 6-12 months should be considered cautionary indications.
  • Patients with low risk of nodal spread may be treated on a MRI-guided local SBRT program.

Exclusion criteria

  • No prior radiation therapy to the target areas
  • Patient able to undergo a MRI exam

Treatment and study plan

Brachytherapy + SBRT

Radiation

Brachytherapy + SBRT

Primary outcomes

  1. Biochemical relapse-free survival

    Time frame: 5-years

    To achieve a 5-year biochemical relapse-free survival of 85%.

Secondary outcomes

  1. Adverse Events

    Time frame: 5-years

    To decrease urinary grade 3 or greater toxicity below 5% and rectal grade 3 or greater toxicity below 2%.

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

MR-guided Brachytherapy and SBRT for Unfavorable Prostate Cancer

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 20, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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