MRI-guided Ultrahypofractionated SBRT Prostate Program
PROJECT#2: MRI-guided Local SBRT Prostate Program
1 other identifier
interventional
40
0 countries
N/A
Brief 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 SBRT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Oct 2025
Typical duration for not_applicable prostate-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2025
CompletedFirst Posted
Study publicly available on registry
August 20, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
August 20, 2025
August 1, 2025
4.7 years
June 19, 2025
August 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Biochemical Relapse-Free Survival
To achieve a 4-year biochemical relapse-free survival of 95%.
5-years
Adverse Events
To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.
5-years
Secondary Outcomes (1)
Quality of Life (QOL) assessment
5-years
Study Arms (3)
Initial Phase
ACTIVE COMPARATORWhole Gland 36.25Gy/5Rx
Study Phase
EXPERIMENTALWhole Gland 27Gy/2Rx
Final Phase
EXPERIMENTALAsymmetrical Whole Gland 27Gy/2Rx
Interventions
Eligibility Criteria
You may qualify if:
- Patients with low to favorable intermediate-risk prostate cancer as per the NCCN stratification criteria .
- No prior radiation therapy to the target areas
- Expected patient survival \>5 years
- Patient able to undergo a MRI exam
- 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 higher risk but low volume disease not candidates for ENI may be treated on an individual basis
You may not qualify if:
- Prior radiation therapy to the target areas
- Expected patient survival below 5 years
- Patient unable to undergo a MRI exam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael Martínez-Monge, M.D.
Clínica Universidad de Navarra
- PRINCIPAL INVESTIGATOR
Luis Fuertes, M.D.
Clínica Universidad de Navarra
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2025
First Posted
August 20, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2030
Last Updated
August 20, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Jul 1st, 2025 to June 30, 2030
- Access Criteria
- On request
On request