Single Dose 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
This study is testing a single high dose of targeted radiotherapy for men with certain types of prostate cancer to see how it affects their health and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | University of Milano Bicocca Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Monza, MB) |
| Trial ID | NCT04831983 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men with histologically confirmed intermediate or high-risk organ-confined prostate adenocarcinoma who meet specific staging and performance criteria.
Not a fit: Patients with advanced disease (≥T3b), high PSA levels, or those who have undergone previous local prostate treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide effective local control of prostate cancer with reduced toxicity compared to traditional treatment methods.
How similar studies have performed: Other studies have shown promising results with similar single-dose radiotherapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Monza, MB
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.