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

NCT05936736 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • Localized Prostate Carcinoma

Interventions

RADIATION

prostate 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

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Nadia Di Muzio, Prof · IRCCS San Raffaele Scientific Institute

  • Andrei Fodor, MD · IRCCS San Raffaele Scientific institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2028-05-31
Completion
2030-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05936736 on ClinicalTrials.gov