RecruitingNot ApplicableNCT05936736

24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer

24 Gy in One Fraction Urethral-sparing "High-Dose-Rate Like" Stereotactic Body RadioTherapy for Prostate Cancer: a Single-center Non-randomized Prospective Clinical Study (PRO-FAST)

Sponsor

IRCCS San Raffaele

Enrollment

70 participants

Start Date

Nov 8, 2023

Study Type

INTERVENTIONAL

Conditions

Localized Prostate Carcinoma

Summary

Patients with prostate cancer who are candidates for stereotactic radiotherapy to the prostate and seminal vesicles will undergo staging exams, which will include prostate specific membrane antigen (PSMA) positron emission tomography-computed tomography (PET-CT). If the PET scan is negative and the uroflowmetry is acceptable, the patients will perform the treatment, after fiducial implantation, simulation CT and magnetic resonance (MR), in a single fraction, delivered with a high-dose-rate (HDR)-like urethral sparing technique. In 70 patients, acute and late toxicity, biochemical control, overall survival, cancer specific-survival, and quality of life (through specific questionnaires) will be evaluated.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a high-dose, single-session radiation treatment approach (24 Gy in one fraction) for prostate cancer that is specifically designed to spare the urethra (the tube carrying urine) from radiation — similar to how high-dose brachytherapy works, but delivered externally using a technique called SBRT (stereotactic body radiotherapy). **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of prostate cancer (any grade group 1–5) - Your cancer has not spread to lymph nodes or other organs (confirmed by imaging) - You have signed informed consent - Your imaging (PET scan and/or MRI) meets guideline requirements **You may NOT be eligible if...** - Imaging shows cancer has spread to lymph nodes or distant sites - You have prior radiation treatment to the prostate area - You have other significant health conditions that make this treatment unsafe 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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Interventions

RADIATIONprostate SBRT

Patients with prostate cancer will be treated with high-dose SBRT to prostate and seminal vesicles, delivered in one fraction, sparing the urethra and generating a dose distribution similar to HDR brachytherapy

Locations(1)

San Raffaele Scientific Institute

Milan, MI, Italy

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NCT05936736

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