An interventional study of Brachytherapy + SBRT in Prostate Cancer, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Enrolling by invitation at 1 site in Spain. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Not applicable, Interventional, and Treatment
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.
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
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 160 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Brachytherapy + MR-guided SBRT
Radiation: Brachytherapy + SBRT
Brachytherapy + SBRT
Biochemical relapse-free survival
To achieve a 5-year biochemical relapse-free survival of 85%.
Time frame: 5-years
Adverse Events
To decrease urinary grade 3 or greater toxicity below 5% and rectal grade 3 or greater toxicity below 2%.
Time frame: 5-years
Plan to share: Yes — On request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 5-years
Access criteria: On request
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Clinica Universidad de Navarra, Universidad de Navarra →