Actively Recruiting
ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0
Led by University of Milano Bicocca · Updated on 2026-02-12
58
Participants Needed
1
Research Sites
443 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven prostate adenocarcinoma
- Intermediate and High risk disease as per NCCN definition
- Presence of a PI-RADS 3-5 dominant intraprostatic lesion on multiparametric MRI
- No lymph node or distant metastases confirmed by Bone Scan and Abdominal CT or PSMA PET-CT
- World Health Organization performance status 0-1
- Life expectancy greater than 5 years as assessed by the investigator
- International Prostate Symptom Score (IPSS) of 15 or less (alpha blockers allowed)
- Prostate gland volume 100 g or less estimated by CT, ultrasound, or MRI
You will not qualify if you...
- Disease stage T3b or higher according to the 8th AJCC classification
- PSA level greater than 20 ng/ml
- Previous prostate local treatment by surgery or transurethral resection
- Previous pelvic radiotherapy
- Presence of periurethral dominant lesion
- Previous invasive cancer unless disease free for at least 5 years
- Active Crohn's Disease or Ulcerative Colitis
- Presence of hip prostheses
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, Italy, 20900
Actively Recruiting
Research Team
S
Stefano Arcangeli, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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