Prostate CancerNCT07132073
MRI-guided Locoregional SBRT Prostate Program
A study testing Brachytherapy + SBRT in people with Prostate Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Brachytherapy + SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No prior radiation therapy to the target areas
- Patient able to undergo a MRI exam
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Clínica Universidad de Navarra Cancer Center
Pamplona, Foral Community of Navarre, 31008
About this study
Official title: MR-guided Brachytherapy and SBRT for Unfavorable Prostate Cancer
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.
Read the 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 .
- Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of QOL with IPSS and EORTC QLQ-PR25
- Conditions
- Prostate Cancer
- Being tested
- Brachytherapy + SBRT
- Keywords
- SBRT, brachytherapy, MR-guided irradiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachytherapy + SBRTRadiation
Brachytherapy + SBRT
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase | Experimental | Brachytherapy + MR-guided SBRT Receives: Radiation: Brachytherapy + SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical relapse-free survival
To achieve a 5-year biochemical relapse-free survival of 85%.
Measured: 5-years
Secondary outcomes (1)
Adverse Events
To decrease urinary grade 3 or greater toxicity below 5% and rectal grade 3 or greater toxicity below 2%.
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Oct 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Martínez-Monge, M.D., Principal investigator, Clinica Universidad de Navarra, Universidad de NavarraLuis Fuertes, M.D., Principal investigator, Clinica Universidad de Navarra, Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132073
- Sponsor's protocol ID
- 2024.199
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-guided Brachytherapy and SBRT for Unfavorable Prostate Cancer
- ClinicalTrials.gov ID
- NCT07132073
- Acronym / sponsor ID
- 2024.199
- Conditions
- Prostate Cancer
- Keywords
- SBRT, brachytherapy, MR-guided irradiation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
- Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of QOL with IPSS and EORTC QLQ-PR25
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase | Experimental | Radiation: Brachytherapy + SBRTBrachytherapy + MR-guided SBRT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- No prior radiation therapy to the target areas
- Patient able to undergo a MRI exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brachytherapy + SBRTBrachytherapy + SBRT | Radiation | Dose Escalation Phase |
Primary outcome
Biochemical relapse-free survival
Time frame: 5-years
To achieve a 5-year biochemical relapse-free survival of 85%.
1 secondary outcome
Adverse Events
Time frame: 5-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. On request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafael Martínez-Monge, M.D. principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
Luis Fuertes, M.D. principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy + SBRT in people with Prostate Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical relapse-free survival (time frame: 5-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.