MRI-guided Locoregional SBRT Prostate Program

NCT07132073 | Enrolling By Invitation

• 1 other identifier: 2024.199
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

SBRT; brachytherapy; MR-guided irradiation

Outcome Measures

Primary Outcomes (1)

• Biochemical relapse-free survival

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

  5-years

Secondary Outcomes (1)

• Adverse Events

  5-years

Study Arms (1)

Dose Escalation Phase

EXPERIMENTAL

Brachytherapy + MR-guided SBRT

Radiation: Brachytherapy + SBRT

Interventions

Brachytherapy + SBRT RADIATION

Brachytherapy + SBRT

Dose Escalation Phase

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clínica Universidad de Navarra Cancer Center

Pamplona, Foral Community of Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rafael Martínez-Monge, M.D.

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

• Luis Fuertes, M.D.

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 20, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: April 29, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5-years
• Access Criteria: On request

Locations

ES (1)