Under construction – not a live service
Sign in
Taking peopleNo phase

Tests adaptive radiotherapy for localized prostate cancer with urinary symptoms

Studies a short-course adaptive radiation treatment in men with early prostate cancer and urinary symptoms.

Plain-language title generated from the registry record
Registry title: Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer

Key facts

Where
Heidelberg and Munich, GermanySee the 2 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with newly diagnosed prostate cancer that has not spread, who also have urinary symptoms and/or an enlarged prostate. They would receive adaptive stereotactic radiotherapy in five weekly sessions.

Age
18 years or older
Sex
Men only
Disease stage
Prostate cancer confirmed by tissue test, not spread (no lymph node or distant metastases), intermediate to high risk (up to cT3a, Gleason score up to 9 and/or PSA up to 20 ng/ml). Seminal vesicle involvement (cT3b) is not allowed.
Earlier treatment
No earlier radiotherapy to the pelvis or the prostate. Planned treatment is CT or MRI online adaptive SBRT of the prostate, as standard care.
Biomarker or test result
Prostate volume above 60 cc and/or IPSS score above 12

Main reasons for not taking part

  • Very high risk cancer needing hormone therapy (ADT and ARPI), for example Gleason 8 or higher with cT3a
  • Cancer in the seminal vesicles (cT3b)
  • Inflammatory bowel disease, earlier pelvic or prostate radiotherapy, or no possibility to have MRI or CT
  • Severe urinary symptoms, such as recent urinary retention of grade 3 or higher
  • Lymph node or distant metastases

Read by machine on 12 November 2026.

Where in Germany

  • Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum HeidelbergHeidelberg, GermanyContact: Jürgen Debus, Prof. Dr. med. Dr. rer. nat.Not yet recruiting
  • Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum LMUMunich, GermanyContact: Claus Belka, Prof. Dr. med.Not yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
University of Zurich
Trial code
NCT06834152
Record updated
6 July 2026
Original description
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.Read full original descriptionShow less

Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer in Patients With Lower Urinary Tract Symptoms and/or Prostate Hyperplasia (X-SMILE)

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.

Inclusion: 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.

Exclusion: 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; 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); 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.

ClinicalTrials.gov NCT06834152