Ablative radiation with a focal boost for unfavorable prostate tumors

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

ABRUPT 2.0 randomizes men with intermediate-unfavorable or selected high-risk organ-confined prostate cancer to either 24 Gy single-dose radiation therapy (SDRT) with a urethra-sparing focal boost or 36.25 Gy stereotactic body radiotherapy (SBRT) delivered in five fractions. The primary endpoint is acute genitourinary (GU) toxicity, with randomization balanced by risk group and conducted 1:1 at a single institution. All patients undergo same-day non-contrast CT and multiparametric MRI for planning, standardized bladder and rectal preparation, and image-guided volumetric arc therapy with strict planning and quality assurance. Androgen deprivation therapy is given per standard of care and staging requires N0M0 by conventional imaging or preferably PSMA PET-CT.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

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

Where it's running

• Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori
  Monza, Mb, Italy Recruiting

Study contacts

• Study coordinator: Stefano Arcangeli, MD
• Email: stefano.arcangeli@unimib.it
• Phone: +39 039 233 3663

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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.