Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07132658

MRI-guided Ultrahypofractionated SBRT Prostate Program

The goal of this clinical trial is to learn if the use of MRI-guided asymmetric ultrahipofractionated irradiation (2 fractions with dose increase in the tumor areas and dose sparing in urethra, rectum and neurovascular bundles) produces similar results in terms of local control and complications to standard 5-fraction SBRT.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Prostate Cancer Program aims to reproduce the results obtained with state-of-the-art brachytherapy or EBRT with the added advantage of convenience and lack of invasiveness.

Who can participate

Healthy volunteers accepted: No

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

Optimal Inclusion Criteria

  • Patients with low to favorable intermediate-risk prostate cancer as per the NCCN stratification criteria .
  • No prior radiation therapy to the target areas
  • Expected patient survival >5 years
  • Patient able to undergo a MRI exam

Cautionary Inclusion 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 higher risk but low volume disease not candidates for ENI may be treated on an individual basis

Exclusion criteria

  • Prior radiation therapy to the target areas
  • Expected patient survival below 5 years
  • Patient unable to undergo a MRI exam

Treatment and study plan

MR-Guided SBRT

Radiation

MR-Guided SBRT

Primary outcomes

  1. Biochemical Relapse-Free Survival

    Time frame: 5-years

    To achieve a 4-year biochemical relapse-free survival of 95%.

  2. Adverse Events

    Time frame: 5-years

    To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.

Secondary outcomes

  1. Quality of Life (QOL) assessment

    Time frame: 5-years

    Determination of QOL with International Prostate Symptom Score (IPSS) and European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-PR25. IPSS ranges from 0 to 35 with higher values representing worse functioning. EORTC QLQ PR-25 ranges from 0-100 with higher values representing better functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

Beatriz Ramos Aguirre, M.S.

CONTACT

[email protected]

+34948255400 ext. 2772

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

PROJECT#2: MRI-guided Local SBRT Prostate Program

Important dates

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

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.