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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Phase | Active Comparator | Whole Gland 36.25Gy/5Rx |
|
| Study Phase | Experimental | Whole Gland 27Gy/2Rx |
|
| Final Phase | Experimental | Asymmetrical Whole Gland 27Gy/2Rx |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-Guided SBRT | Radiation | MR-Guided SBRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5-years |
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Optimal Inclusion Criteria
Cautionary Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Ramos Aguirre, M.S. | Contact | +34948255400 | 2772 | ucicec@unav.es |
| Name | Affiliation | Role |
|---|---|---|
| Rafael MartÃnez-Monge, M.D. | ClÃnica Universidad de Navarra | Principal Investigator |
| Luis Fuertes, M.D. | ClÃnica Universidad de Navarra | Principal Investigator |
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On request
Jul 1st, 2025 to June 30, 2030
On request
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |