Real-time monitoring and appropriate margin selection in linac-based prostate SBRT: Analysis of two different intrafraction motion monitoring systems.
Denis Panizza, Valeria Faccenda, Chiara Ingraito...
https://pubmed.ncbi.nlm.nih.gov/40802285Actively Recruiting
Age: 18Years - 90Years
MALE
ID07407608
Single-Dose Image-Guided Radiotherapy With Focal Boost to MRI-Defined Tumor for Intermediate Unfavorable and High Risk Prostate Cancer
Led by University of Milano Bicocca · Updated on 2026-02-12
58
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to treat intermediate unfavorable and selected high-risk prostate cancer patients using Single Dose Radiation Therapy (SDRT) with a focal boost to the MRI-defined tumor area. This phase II trial focuses on acute genitourinary toxicity as the primary outcome, comparing the safety and side effects of this single-dose treatment to a five-dose stereotactic body radiotherapy (SBRT) regimen. The study aims to determine if the shorter treatment can achieve similar toxicity levels and is suitable for further research. Participants are randomly assigned to one of two treatment groups. One group receives 36.25 Gy SBRT delivered in five fractions over two weeks, while the other receives a single 24 Gy SDRT dose with urethra-sparing and a focal boost up to 27 Gy. Both treatments utilize advanced image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with precise planning and continuous motion monitoring using real-time tracking systems. Bladder and rectal preparation protocols differ between groups to optimize treatment delivery and protect surrounding tissues. During the study, participants undergo non-contrast CT and multiparametric MRI scans for treatment planning, with various organs at risk carefully outlined to minimize exposure. Researchers monitor acute and late genitourinary and gastrointestinal side effects over several years, along with quality of life, urinary symptoms, erectile function, and biochemical relapse using standardized questionnaires and PSA testing. The trial includes close safety monitoring with interim analyses and follow-up assessments at 3 months, 1, 2, and 5 years post-treatment, with total participation lasting several years.
CONDITIONS
Brief Title
ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0
Who Can Participate
Age: 18Years - 90Years
MALE
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate adenocarcinoma
- Intermediate or high-risk disease according to NCCN
- Presence of a PI-RADS 3-5 dominant lesion on multiparametric MRI
- No lymph node or distant metastases on staging scans
- WHO performance status 0-1
- Life expectancy greater than 5 years
- IPSS score 15 or less (alpha blockers allowed)
- Prostate gland volume 100 grams or less by CT, ultrasound, or MRI
You will not qualify if you...
- Disease stage T3b or higher
- PSA level above 20 ng/ml
- Previous local prostate surgery or transurethral resection
- Prior pelvic radiotherapy
- Presence of periurethral dominant lesion
- History of invasive malignancy unless disease-free for 5 years
- Active Crohn's disease or ulcerative colitis
- Presence of hip prostheses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments including imaging and clinical evaluation
Treatment
Duration - Up to 2 weeks depending on assigned treatment arm
Participants receive either five fractions of stereotactic body radiotherapy (SBRT) over two weeks or a single dose of single-dose radiation therapy (SDRT) with focal boost to the tumor.
Five treatment visits over two weeks for SBRT arm or 1 treatment visit for SDRT arm, plus imaging and preparation visits as part of treatment delivery
Follow-up
Duration - Up to 5 years
Participants are monitored for treatment-related adverse events, quality of life, and disease status over several years after treatment.
Scheduled follow-up visits at 3 months, 1 year, 2 years, and 5 years after treatment
Trial Site Locations
Total: 1 location
1
Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, Italy, 20900
Actively Recruiting
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Research Team
S
Stefano Arcangeli, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Intrafraction Prostate Motion Management During Dose-Escalated Linac-Based Stereotactic Body Radiation Therapy.
Denis Panizza, Valeria Faccenda, Raffaella Lucchini...
https://pubmed.ncbi.nlm.nih.gov/35463373Treatment Optimization in Linac-Based SBRT for Localized Prostate Cancer: A Single-Arc versus Dual-Arc Plan Comparison.
Denis Panizza, Valeria Faccenda, Stefano Arcangeli...
https://pubmed.ncbi.nlm.nih.gov/38201441Dosimetric Impact of Intrafraction Prostate Motion and Interfraction Anatomical Changes in Dose-Escalated Linac-Based SBRT.
Valeria Faccenda, Denis Panizza, Martina Camilla Daniotti...
https://pubmed.ncbi.nlm.nih.gov/36831496Stereotactic body radiotherapy with a focal boost to the intraprostatic tumor for intermediate and high risk prostate cancer: 5-year efficacy and toxicity in the hypo-FLAME trial.
Cédric Draulans, Karin Haustermans, Floris J Pos...
https://pubmed.ncbi.nlm.nih.gov/39362607Intensity-modulated moderately hypofractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-C): early toxicity results from a randomised, open-label, phase 3, non-inferiority trial.
Alison C Tree, Victoria Hinder, Andrew Chan...
https://pubmed.ncbi.nlm.nih.gov/40517778Ablative Radiation Therapy for Unfavorable Prostate Tumors (ABRUPT): Preliminary Analysis of Toxicity and Quality of Life from a Prospective Study.
Stefano Arcangeli, Chiara Chissotti, Federica Ferrario...
https://pubmed.ncbi.nlm.nih.gov/38971384