Focal Micro-boost Radiotherapy for Localized Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

HYPO62 SPECIAL is a single-center, prospective observational cohort that explores a moderately hypofractionated radiotherapy plan with a focal micro-boost to dominant intraprostatic lesions identified by multiparametric MRI. The approach builds on prior data suggesting that escalating dose to the tumor center may improve biochemical control while limiting toxicity. Participants receive whole-gland radiotherapy delivered in 20 fractions, plus a focal boost to MRI-visible dominant lesions. Outcomes of interest include oncologic efficacy and safety/tolerance of this focal boosting strategy. The study is conducted by the Regina Elena Cancer Institute in Rome, Italy, and is non-interventional in design.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Regina Elena National Cancer Institute
  Rome, Lazio, Italy Recruiting

Study contacts

• Study coordinator: Giuseppe Sanguineti, MD
• Email: giuseppe.sanguineti@ifo.it
• Phone: Italy: +39 0652665031

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.