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POst-Prostatectomy Ablative Radiation Therapy

Recruitingn/aAges 18 Years - 90 YearsMaleUniversity of Milano Bicocca
NCT04831970 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The use of hypofractionated radiotherapy for prostate cancer has matured to a point that in current guidelines extremely hypofractionated image-guided IMRT regimens (6 Gy per fraction or greater) can be considered an alternative to conventionally fractionated regimens at clinics with appropriate technology, physics and clinical expertise. The delivery of fewer and larger fractions with hypofractionation compared to conventional radiotherapy might effectively improve the therapeutic ratio while maintaining isoeffective tumour doses, thus, shortening overall treatment time. In the present study, patients will undergo postoperative image-guided SBRT by means of volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Normal tissue sparing and delivery accuracy are accomplished by the use of devices that ensure sta

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📋 Eligibility rules (as published)
INCLUSION CRITERIA * Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy). * Pathologic T3N0/Nx disease or pathologic T2N0/Nx disease, with or without a positive prostatectomy surgical margin * Post-radical prostatectomy PSA of ≥ 0.1 - \< 2.0 ng/mL. * Clinical local relapse assessed by Magnetic Resonance Imaging (MRI) of the pelvis * ECOG performance status of 0-1 * No distant metastases at restaging (in case of biochemical failure), within 60 days prior to registration * Patients can be on androgen deprivation therapy * Ability to understand and willingness to sign a study-specific informed consent prior to study entry EXCLUSION CRITERIA * N1 and or M1 patients * Prior radiation of any kind to the prostate gland or pelvis * Prior brachytherapy is not allowed * History of inflammatory colitis or other active severe comorbidities * Patients who are on immunosuppressant medication
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What it tests

  • Not listed
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Where

2 sites
Radiation Oncology, Humanitas Cancer Center (Humanitas University)
Rozzano, Italy
Radiation Oncology, ASST Monza (University of Milan Bicocca)
Monza, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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