RecruitingNCT06941363

Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence


Sponsor

University of Milano Bicocca

Enrollment

50 participants

Start Date

May 2, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Recently, the Radiation Oncology Department at Fondazione IRCCS San Gerardo dei Tintori has been renovated and has been equipped with cutting edge technologies to treat prostate cancer. Specifically, the now available technology can track organ motion in real time, thus allowing improved precision in radiation delivery, with increased protection of the surrounding organs at risk. These facilities have already enabled the kickoff of two prospective observational trials, the ABRUPT and the POPART, which are currently ongoing in the treatment of intact prostate and the biochemical recurrence, respectively. Taken together, these observations provide the basis for the prospective clinical study herein proposed. Patients enrolled in the study will undergo salvage single stereotactic RT to the prostate bed by means of image guided volumetric intensity-modulated arc technique (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures, with emphasis on normal tissue sparing and and pinpoint delivery accuracy via the use of devices that ensure stability and beam location reproducibility


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a short-course, high-dose radiation treatment (ultrahypofractionation) to the prostate bed for men whose PSA level has risen after prostate removal surgery — a sign the cancer may be coming back. **You may be eligible if...** - You are a man aged 18 or older - You have had a radical prostatectomy (surgical removal of the prostate) for prostate adenocarcinoma at any point in the past - Your PSA is between 0.1 and less than 2.0 ng/mL (either persistently elevated or newly risen after being undetectable) - There is no evidence of cancer spread to lymph nodes or distant sites on a PSMA PET scan - Your performance status is good (ECOG 0–1) **You may NOT be eligible if...** - You have confirmed spread to lymph nodes or other organs - You have received prior radiation to the pelvis - You have symptoms of urinary blockage or significant bowel problems 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

RADIATIONSDRT

Salvage Single Dose Radiation Therapy (SDRT) to the prostate bed up to 17 Gy


Locations(1)

Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori (University of Milan Bicocca)

Monza, Italy, Italy

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NCT06941363


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