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Taking people in ItalyNo phase

Single-dose focused radiotherapy for prostate cancer that has not spread

Looks at one-session radiotherapy with extra dose to the MRI-seen tumor in prostate cancer.

Plain-language title generated from the registry record
Registry title: ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0

Key facts

Where
Monza, ItalySee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with prostate cancer that has not spread outside the prostate. It tests one single high dose of radiotherapy, with an extra dose to the tumour seen on MRI.

Age
18 to 90 years
Sex
Men only
Disease stage
Intermediate or high risk prostate adenocarcinoma (NCCN definition), with a PI-RADS 3-5 main lesion on MRI, no spread to lymph nodes or distant organs (N0M0), prostate volume 100 g or less, and IPSS score 15 or less.
Earlier treatment
No earlier surgery, cryotherapy or transurethral resection of the prostate. No earlier radiotherapy to the pelvis.
Biomarker or test result
PSA must be 20 ng/ml or lower.

Main reasons for not taking part

  • Disease T3b or more advanced (8th AJCC classification)
  • PSA above 20 ng/ml
  • Main lesion next to the urethra
  • Other invasive cancer in the past 5 years
  • Active Crohn's disease or ulcerative colitis, or hip prostheses

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 90 years old?

Source: NCT07407608, who can take part

Where in Italy

  • Radiation Oncology, Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyContact: Stefano Arcangeli, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
University of Milano Bicocca
Trial code
NCT07407608
Record updated
12 February 2026
Original description
Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. The results of the study will enable us to find out if the new, shorter treatment (1 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.Read full original descriptionShow less

Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. The results of the study will enable us to find out if the new, shorter treatment (1 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.

Inclusion: Histologically proven prostate adenocarcinoma; Intermediate and High risk disease, as per the NCCN definition; a PI-RADS 3-5 dominant intraprostatic lesion on multiparametric MRI (mpMRI); N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) PSMA PET-CT; World Health Organization performance status 0-1; Life expectancy of > 5 years, in the opinion of the investigator; IPSS score must be ≤ 15 (alpha blockers allowed); Prostate gland volume ≤100 g as estimated by computed tomography (CT), ultrasound, or MRI.

Exclusion: Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) or transurethral resection; Previous radiotherapy to the pelvis; ≥T3b disease according to the 8th AJCC classification; Previous invasive malignancy unless disease free for a minimum of 5 years; Active Crohn's Disease or Ulcerative Colitis; PSA>20 ng/ml; Presence of a periurethral dominant lesion; Presence of hip prostheses.

ClinicalTrials.gov NCT07407608