ABlative Radiotherapy (for) Unfavorable Prostate Tumors
Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer
University of Milano Bicocca
30 participants
Apr 15, 2021
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 ≤ 19 (alpha blockers allowed);
Exclusion Criteria6
- ≥T3b 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;
Locations(1)
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NCT04831983