Actively Recruiting
Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)
Led by University of Zurich · Updated on 2026-02-09
75
Participants Needed
3
Research Sites
382 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this phase II international multicenter study is to evaluate the safety, feasibility, and efficacy of CT or MRI-adaptive SBRT, delivered in five weekly fractions, in patients with newly diagnosed localized prostate cancer who have lower urinary tract symptoms and/or prostatic hyperplasia.
CONDITIONS
Official Title
Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed localized prostate cancer
- Planned treatment with definitive CT or MRI online adaptive SBRT following the PACE trial dosing schedule
- Intermediate to very high-risk localized prostate cancer (clinical stage 64 cT3a, Gleason score 64 9, and/or PSA 64 20 ng/ml)
- Prostate volume greater than 60 cc and/or International Prostate Symptom Score (IPSS) greater than 12
You will not qualify if you...
- Very high-risk localized prostate cancer requiring ADT and ARPI (Gleason 65 8 and clinical stage cT3a)
- Involvement of seminal vesicles (clinical stage cT3b)
- Contraindications to definitive CT or MRI-adaptive radiotherapy, including inflammatory bowel disease, prior pelvic or prostate radiotherapy, or contraindications for MRI or CT
- Severe genitourinary symptoms such as recent urinary retention grade 65 3 by CTCAE v5.0
- Presence of lymph node or distant metastases
- Participation in another clinical trial that could affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Not Yet Recruiting
2
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum LMU
Munich, Bavaria, Germany, 81377
Not Yet Recruiting
3
University Hospital Zurich, Department of Radio-Oncology
Zurich, Canton of Zurich, Switzerland, 8090
Actively Recruiting
Research Team
R
Radiation Oncology Study Office
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
2
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