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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
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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Zurich, Department of Radio-Oncology
Coordinator of this site? Confirm its status
ZurichSwitzerlandRecruiting
Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum Heidelberg
Coordinator of this site? Confirm its status
HeidelbergGermanyNot yet recruiting
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum LMU
Coordinator of this site? Confirm its status
MunichGermanyNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.