MRI-guided Locoregional SBRT Prostate Program

MR-guided Brachytherapy and SBRT for Unfavorable Prostate Cancer

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07132073

Enrollment

Registered

2025-08-20

Start date

2025-10-01

Completion date

2030-06-30

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

SBRT, brachytherapy, MR-guided irradiation

Brief summary

Detailed description

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

Interventions

RADIATIONBrachytherapy + SBRT

Brachytherapy + SBRT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Biochemical relapse-free survival	5-years	To achieve a 5-year biochemical relapse-free survival of 85%.

Secondary

Measure	Time frame	Description
Adverse Events	5-years	To decrease urinary grade 3 or greater toxicity below 5% and rectal grade 3 or greater toxicity below 2%.

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORRafael Martínez-Monge, M.D.

Clínica Universidad de Navarra

PRINCIPAL_INVESTIGATORLuis Fuertes, M.D.