RecruitingNCT04831983

ABlative Radiotherapy (for) Unfavorable Prostate Tumors

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

30 participants

Start Date

Apr 15, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a high-dose, very precise form of radiation therapy (called ablative radiotherapy or SBRT) for intermediate- and high-risk prostate cancer. The aim is to deliver a powerful cancer-killing dose in fewer sessions while protecting surrounding healthy tissue. **You may be eligible if...** - You have been diagnosed with prostate cancer (confirmed by biopsy) - Your cancer is intermediate- or high-risk (based on standard classification) - Cancer has not spread to your lymph nodes or other organs - You are in reasonably good health (ECOG 0–2) with a life expectancy of more than 5 years - Your urinary symptom score is not severely elevated **You may NOT be eligible if...** - Your cancer has spread extensively beyond the prostate capsule (T3b or higher) - Your PSA has ever been above 20 ng/mL - You have had prior prostate surgery (radical prostatectomy or cryotherapy) - You have had prior pelvic radiation - You have active Crohn's disease or ulcerative colitis 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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Locations(1)

Radiation Oncology, ASST Monza (University of Milan Bicocca)

Monza, MB, Italy

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NCT04831983


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