NCT06834152Recruiting
Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer
Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer in Patients With Lower Urinary Tract Symptoms and/or Prostate Hyperplasia (X-SMILE)
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 75 (estimated)
- First submitted
- 6 Feb 2025
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- University of Zurich
- Diseases
- Prostate cancer
- NCT number
- NCT06834152
What you commit to
- Study type: Observational
- Planned participants: 75
- From 1 Mar 2024 to the primary completion date, 1 Sept 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications against definitive CT or MRI-adaptive radiotherapy of the prostate, e.g. inflammatory bowel disease (IBD); previous radiotherapy in the pelvis, previous local radiotherapy of the prostate, contraindication for MRI or CT;
Other illness
- Very high risk localized prostate cancer with indication for ADT and ARPI (i.e. Gleason ≥ 8 and cT3a)
- Lymph node metastases or distant metastases (i.e. no localised prostate cancer);
Other
- Involvement of seminal vesicles (cT3b)
- Patients with severe genitourinary symptoms (e.g. recent urinary retention ≥ grade 3 according CTCAE v.5.0);
- Participation in a clinical trial which might influence the results of this project.
Who the study is looking for
- histologically confirmed localized prostate cancer
- planned treatment is SBRT according to standard of care and consists of definitive CT or MRI online adaptive SBRT of the prostate according to the PACE trial which includes a total dose to clinical target volume 1 (CTV1, i.e. prostate and proximal 1 cm of the seminal vesicle) of 40.0 Gy in 5 weekly fractions (single dose of 8.0 Gy) and total dose to planning target volume 1 (PTV1) of 37.5 Gy in 5 weekly fractions (single dose of 7.5 Gy) with a compromise for bowel sparing allowed. For patients with unfavorable intermediate to very high-risk disease (according to NCCN guidelines) a total dose to the planning target volume 2 (PTV2, i.e. proximal 1-2 cm of the seminal vesicle) of 32.5 Gy in 5 weekly fractions (single dose of 6.5 Gy) will be delivered.
- intermediate to (very) high risk localized prostate cancer (≤ cT3a and Gleason score ≤ 9 and/or PSA ≤ 20 ng/ml)
- prostate volume \> 60 cc and/or IPSS \> 12;
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Zurich, Department of Radio-Oncology Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Not yet recruiting |
| Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum LMU Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.