Single Dose Radiotherapy 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

This observational trial investigates the effects of a single dose of 21 Gy whole gland radiotherapy combined with a 24 Gy boost to specific tumor areas in patients with intermediate unfavorable and selected high-risk prostate cancer. The treatment utilizes image-guided volumetric modulated arc therapy (IGRT-VMAT) to ensure precise targeting while minimizing damage to surrounding healthy tissues. Patients will receive androgen deprivation therapy as per standard care, and their treatment-related toxicity and quality of life will be monitored over time using validated assessment tools.

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;
* 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 CRITERIA:

* ≥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;

Where it's running

• Radiation Oncology, ASST Monza (University of Milan Bicocca)
  Monza, Mb, Italy Recruiting

Study contacts

• Study coordinator: Stefano Arcangeli, Md
• Email: stefano.arcangeli@unimib.it
• Phone: +39 039-2333663

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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.