RecruitingNCT07407608

ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0

Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer

Sponsor

University of Milano Bicocca

Enrollment

58 participants

Start Date

Jan 28, 2026

Study Type

OBSERVATIONAL

Conditions

Prostate Cancer Prostate Cancer (Adenocarcinoma)Prostate Cancer Non-Metastatic

Summary

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. The results of the study will enable us to find out if the new, shorter treatment (1 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates high-dose, precisely targeted radiation (ablative radiotherapy) aimed directly at the main tumor in the prostate for men with intermediate- or high-risk prostate cancer that has not spread to lymph nodes or distant organs. **You may be eligible if...** - You have been confirmed to have prostate cancer (adenocarcinoma) - Your cancer is classified as intermediate or high risk - Your prostate MRI shows a localized lesion that can be targeted - Your cancer has not spread to lymph nodes or distant organs - Your urinary symptoms are mild (IPSS score 15 or below) - Your prostate is 100g or smaller - Your overall health is good and life expectancy is more than 5 years **You may NOT be eligible if...** - Your cancer has grown extensively into surrounding tissue (stage T3b or above) - Your PSA level is above 20 ng/mL - You have had previous prostate surgery, cryotherapy, or pelvic radiation - You have active Crohn's disease or ulcerative colitis - You have hip replacements - You had another cancer within the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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