Actively Recruiting
ABlative Radiotherapy (for) Unfavorable Prostate Tumors
Led by University of Milano Bicocca · Updated on 2024-01-03
30
Participants Needed
1
Research Sites
415 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.
CONDITIONS
Official Title
ABlative Radiotherapy (for) Unfavorable Prostate Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven prostate adenocarcinoma
- Intermediate and High risk disease, as per the NCCN definition
- N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) Choline or PSMA PET-CT
- ECOG performance status between 0 and 2
- Life expectancy of > 5 years, in the opinion of the investigator
- IPSS score must be �b4 19 (alpha blockers allowed)
You will not qualify if you...
- �b43b disease according to the 8th AJCC classification
- PSA >20 ng/ml at any time point
- Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)
- Previous radiotherapy to the pelvis
- Previous invasive malignancy unless disease free for a minimum of 5 years
- Active Crohn's Disease or Ulcerative Colitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Radiation Oncology, ASST Monza (University of Milan Bicocca)
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
0
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