Actively Recruiting

Age: 18Years - 90Years
MALE
NCT04831983

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

Age: 18Years - 90Years
MALE

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Radiation Oncology, ASST Monza (University of Milan Bicocca)

Monza, MB, Italy, 20900

Actively Recruiting

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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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