Prostate CancerNCT07132658
MRI-guided Ultrahypofractionated SBRT Prostate Program
A study testing MR-Guided SBRT in people with Prostate Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial summary
The goal of this clinical trial is to learn if the use of MRI-guided asymmetric ultrahipofractionated irradiation (2 fractions with dose increase in the tumor areas and dose sparing in urethra, rectum and neurovascular bundles) produces similar results in terms of local control and complications to standard 5-fraction… Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MR-Guided SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- 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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Prior radiation therapy to the target areas
- Expected patient survival below 5 years
- Patient unable to undergo a MRI exam
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PROJECT#2: MRI-guided Local SBRT Prostate Program
The goal of this clinical trial is to learn if the use of MRI-guided asymmetric ultrahipofractionated irradiation (2 fractions with dose increase in the tumor areas and dose sparing in urethra, rectum and neurovascular bundles) produces similar results in terms of local control and complications to standard 5-fraction SBRT.
Read the detailed description
The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Prostate Cancer Program aims to reproduce the results obtained with state-of-the-art brachytherapy or EBRT with the added advantage of convenience and lack of invasiveness.
- Conditions
- Prostate Cancer
- Being tested
- MR-Guided SBRT
- Keywords
- Prostate Cancer, NCCN Low Risk, NCCN Favorable Intermediate Risk
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-Guided SBRTRadiation
MR-Guided SBRT
| Study group | Role | What they receive |
|---|---|---|
| Initial Phase | Active comparator | Whole Gland 36.25Gy/5Rx Receives: Radiation: MR-Guided SBRT |
| Study Phase | Experimental | Whole Gland 27Gy/2Rx Receives: Radiation: MR-Guided SBRT |
| Final Phase | Experimental | Asymmetrical Whole Gland 27Gy/2Rx Receives: Radiation: MR-Guided 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 4-year biochemical relapse-free survival of 95%.
Measured: 5-years
Adverse Events
To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
Measured: 5-years
Secondary outcomes (1)
Quality of Life (QOL) assessment
Determination of QOL with International Prostate Symptom Score (IPSS) and European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-PR25. IPSS ranges from 0 to 35 with higher values representing worse functioning. EORTC QLQ PR-25 ranges from 0-100 with higher values representing better functioning.
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 (estimated)
- 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
- Non-randomised
- Intervention model
- Sequential
- 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
- NCT07132658
- Sponsor's protocol ID
- 2024.198
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2025
- Last updated
- 20 Aug 2025
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROJECT#2: MRI-guided Local SBRT Prostate Program
- ClinicalTrials.gov ID
- NCT07132658
- Acronym / sponsor ID
- 2024.198
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, NCCN Low Risk, NCCN Favorable Intermediate Risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- 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 goal of this clinical trial is to learn if the use of MRI-guided asymmetric ultrahipofractionated irradiation (2 fractions with dose increase in the tumor areas and dose sparing in urethra, rectum and neurovascular bundles) produces similar results in terms of local control and complications to standard 5-fraction SBRT.
Detailed description
The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Prostate Cancer Program aims to reproduce the results obtained with state-of-the-art brachytherapy or EBRT with the added advantage of convenience and lack of invasiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Initial Phase | Active comparator | Radiation: MR-Guided SBRTWhole Gland 36.25Gy/5Rx |
| Study Phase | Experimental | Radiation: MR-Guided SBRTWhole Gland 27Gy/2Rx |
| Final Phase | Experimental | Radiation: MR-Guided SBRTAsymmetrical Whole Gland 27Gy/2Rx |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Prior radiation therapy to the target areas
- Expected patient survival below 5 years
- Patient unable 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 |
|---|---|---|
| MR-Guided SBRTMR-Guided SBRT | Radiation | Final Phase, Initial Phase, Study Phase |
Primary outcome
Biochemical Relapse-Free Survival
Time frame: 5-years
To achieve a 4-year biochemical relapse-free survival of 95%.
Adverse Events
Time frame: 5-years
To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
1 secondary outcome
Quality of Life (QOL) assessment
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 20 Aug 2025.
- 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
Questions about this trial
What is this clinical trial studying?
A study testing MR-Guided SBRT in people with Prostate Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra.
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 0 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Beatriz Ramos Aguirre, M.S. (+34948255400 ext. 2772, ucicec@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Relapse-Free Survival (time frame: 5-years). The study lists 2 primary outcomes in all. 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 20 Aug 2025.