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NCT07132658Not yet recruiting

MRI-guided Ultrahypofractionated SBRT Prostate Program

PROJECT#2: MRI-guided Local SBRT Prostate Program

Source: ClinicalTrials.gov · Last updated 20 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
19 Jun 2025
Start date
1 Oct 2025
Primary completion date
30 Jun 2030
Lead sponsor
Clinica Universidad de Navarra, Universidad de Navarra
NCT number
NCT07132658

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 1 Oct 2025 to the primary completion date, 30 Jun 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior radiation therapy to the target areas

Other

  • Expected patient survival below 5 years
  • Patient unable to undergo a MRI exam

Criteria the registry did not label

  • 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

Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.