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โ† Trials
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Focal Micro-boost Strategy in Patients With Intermediate- to High-risk Prostate Cancer (IR-HR PCa) Undergoing Hypofractionated Radiotherapy

Recruitingn/aAges 18 Years - 99 YearsMaleRegina Elena Cancer Institute
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In plain words

What the trial is, and whether it could suit you

HYPO62 SPECIAL is a monocentric, prospective observational cohort study promoted by IFO-IRE/ISG, designed to evaluate a moderately hypofractionated radiotherapy strategy with focal micro-boost in patients with localized intermediate- or high-risk prostate cancer. Definitive radiotherapy is an established treatment option for localized prostate cancer. Over recent decades, technical advances such as 3D conformal radiotherapy, IMRT, and multiparametric MRI have enabled more precise dose delivery and better identification of dominant intraprostatic lesions. Since most local recurrences occur in the original tumor area, selective dose escalation to MRI-visible dominant lesions represents a rational strategy to improve biochemical control while limiting toxicity to surrounding organs at risk. The study is based on previous evidence, including FLAME and DELINEATE, showing that focal boosting

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older. * Histologically confirmed diagnosis of prostate adenocarcinoma. * Intermediate or high-risk prostate cancer according to NCCN criteria. * No regional or distant metastases. * ECOG performance status 0-1. * Eligibility for moderately hypofractionated radiotherapy in 20 fractions. * Presence of at least one PI-RADS 4 or 5 lesion on multiparametric MRI, or a PI-RADS 3 lesion confirmed as positive at pathology. * Ability to understand the Italian language and adhere to study procedures. * Written informed consent for participation and data processing. Exclusion Criteria: * Previous local prostate treatment with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy. * Previous pelvic radiotherapy. * Presence of nodal or distant metastases confirmed by MRI or PET/CT.
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What it tests

  • Not listed
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Where

1 site
IRCCS Regina Elena National Cancer Institute
Rome, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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