MRI-guided Locoregional SBRT Prostate Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brachytherapy + SBRT.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MR-guided Brachytherapy and SBRT for Unfavorable Prostate Cancer
Overview
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.
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
- Radiation Brachytherapy + SBRT
Brachytherapy + SBRT
Primary outcome measures
- Biochemical relapse-free survival [Time frame: 5-years]
Secondary outcome measures (1)
- Adverse Events [Time frame: 5-years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Clínica Universidad de Navarra Cancer Center — Pamplona
Identifiers
NCT: NCT07132073 · 2024.199