Localized Prostate CarcinomaX-SMILENCT06834152
Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer
An observational study of Localized Prostate Carcinoma and Prostate Cancer (Adenocarcinoma), run by University of Zurich at 3 sites in 2 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Carcinoma, Prostate Cancer (Adenocarcinoma), Prostate Hyperplasia
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Mar 2024to 30 Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This international multicenter prospective phase II study, conducted in collaboration with several academic hospitals in Switzerland and Germany, will include patients with histologically confirmed intermediate to (very) high risk localized prostate cancer with lower urinary tract symptoms and/or prostate hyperplasia. These patients are planned to receive weekly CT or MRI online adaptive SBRT for localized prostate cancer.
Who may be able to join
- 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;
Who cannot join
- Very high risk localized prostate cancer with indication for ADT and ARPI (i.e. Gleason ≥ 8 and cT3a)
- Involvement of seminal vesicles (cT3b)
- 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;
- Patients with severe genitourinary symptoms (e.g. recent urinary retention ≥ grade 3 according CTCAE v.5.0);
- Lymph node metastases or distant metastases (i.e. no localised prostate cancer);
- Participation in a clinical trial which might influence the results of this project.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Germany2 sites, 2 recruiting
- Not yet recruiting
Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Jürgen Debus, Prof. Dr. med. Dr. rer. nat., juergen.debus@med.uni-heidelberg.de
Jürgen Debus, Prof. Dr. med. Dr. rer. nat.
- Not yet recruiting
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum LMU
Munich, Bavaria, 81377
Claus Belka, Prof. Dr. med., Claus.Belka@med.uni-muenchen.de
Claus Belka, Prof. Dr. med.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Department of Radio-Oncology
Zurich, Canton of Zurich, 8090
Matthias Guckenberger, Prof. Dr. med., +41 44 255 31 50, matthias.guckenberger@usz.ch
Tiuri E. Kroese, MD PhD
About this study
Official title: 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.
Read the detailed description
Background: Stereotactic body radiotherapy (SBRT) for localized prostate cancer has demonstrated non-inferior oncological outcomes and toxicity profiles to conventionally or moderately hypofractioned radiotherapy regimens, while offering the advantage of shorter treatment durations. However, SBRT may not be suitable for all patients, particularly those with lower urogenital tract symptoms and/or prostatic hyperplasia.
Methods: This study aims to evaluate the safety and efficacy of weekly computed tomography (CT) or magnetic resonance image-guided (MRI) online adaptive SBRT in patients with intermediate to (very) high-risk localized prostate cancer who present with lower urinary tract symptoms (International Prostate Symptom Score [IPSS] > 12) and/or have prostate hyperplasia (prostate volume >60 mL). The primary outcome measure is urogenital toxicity grade ≥3 within 3 months after completion of SBRT (according to CTCAE V5.0 and RTOG) or discontinuation of therapy. Our aim is to show that the event rate is at 3% below a clinically acceptable threshold, which is set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30. In our validation cohort we assume that around 3% of patients will have grade 3 long-term urogenital toxicity (i.e. 2 patients). The rate of treatment discontinuation within 3 months is considered negligible. Our aim is to show with high probability, that the event rate is below a clinically acceptable threshold, which is set at 12%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 75.
- Conditions
- Localized Prostate Carcinoma, Prostate Cancer (Adenocarcinoma), Prostate Hyperplasia, Lower Urinary Track Symptoms
- Being tested
- radiotherapy
- Keywords
- radiotherapy, SBRT, MRI, CT, stereotactic radiotherapy, localized prostate cancer, lower urinary tract symptoms, prostate hyperplasia, prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
Patients with prostate cancer in the medium or high risk range who are planned to receive definitive CT or MRI-adaptive SBRT.
| Study group | Role | What they receive |
|---|---|---|
| Pilot study | For our pilot study, we assumed that around 3% of patients would have grade 3 acute urogenital toxicity (i.e. 1 patient). The rate of treatment discontinuation within 3 months was considered negligible. Our aim was to show with high probability, that the event rate was below a clinically acceptable threshold, which was set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30. Dropouts prior to treatment start will be replaced. Receives: Radiation: radiotherapy | |
| Validation Cohort | For our validation study, we assume that around 3% of patients will have grade 3 long-term urogenital toxicity (i.e. 2 patients). The rate of treatment discontinuation within 3 months is considered negligible. Our aim is to show with high probability, that the event rate is below a clinically acceptable threshold, which is set at 12%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 75. Dropouts prior to treatment start will be replaced. Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute grade ≥ III urogenital toxicity
The primary endpoint is acute grade ≥ III urogenital toxicity ≤3 months after completion of radiotherapy (according to the NCI CTCAE V5 or RTOG) or treatment discontinuation related to treatment.
Measured: ≤ 3 months after completion of radiotherapy
Secondary outcomes (9)
Gastrointestinal toxicity of grade ≥3
Gastrointestinal toxicity of grade ≥3 within 3 months after completion of radiotherapy (according to CTCAE V5.0 and RTOG)
Measured: ≤ 3 months after completion of radiotherapy
Mortality
Mortality (related to treatment and/or disease).
Measured: ≤1 year after initiation of radiotherapy
Urogenital and gastrointestinal toxicities
Number of urogenital and gastrointestinal toxicities within 5 years after completion of radiotherapy and their severity.
Measured: ≤ 5 years after completion of radiotherapy
Biochemical progression-free survival
Biochemical progression-free survival (determined from the start of therapy until the occurrence of PSA recurrence according to the Phoenix criteria i.e. post- therapeutic PSA nadir + 2 ng/ml),
Measured: ≤ 5 years after completion of radiotherapy
Hormonal therapy-free survival
Hormonal therapy-free survival (determined from the start of therapy until the start of hormonal therapy,
Measured: ≤ 5 years after completion of radiotherapy
Overall survival
overall survival (defined from the start of therapy until death or censoring)
Measured: 5 years after completion of radiotherapy
Quality-of-life questionnaire C-30 from the European Organisation for Research and Treatment of Cancer
Quality-of-life measured using the EORTC QLQ-C30 questionnaire during and after treatment
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: ≤ 5 years after completion of radiotherapy
Uroflowmetry (optional)
Uroflowmetry prior to the start of radiotherapy (optional study procedure)
Measured: Uroflowmetry ≤ 6 weeks prior to the start of radiotherapy
Quality-of-life questionnaire PR25 of the European Organisation for Research and Treatment of Cancer
Quality-of-life measured using the QLQ-PR25 questionnaire during and after treatment
All of the scales and single-item measures range in score from 0 to 100. A high score for the Sexual Activity and Sexual Functioning scales represents a high level of functioning, whereas a high score for the Urinary, Bowel, and Hormonal Treatment-Related symptoms scales and Incontinence Aid item represents a high level of symptomatology or problems.
Measured: ≤ 5 years after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Mar 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Localized Prostate CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Guckenberger, Prof. Dr. med., Study chair, University of ZurichTiuri E. Kroese, MD, PhD, Principal investigator, University of ZurichMatthias Guckenberger, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834152
- Sponsor's protocol ID
- RAO-24-014
- Acronym
- X-SMILE
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this trial after de-identification. Other documents may be shared include the study protocol.
Publications
Kroese T, Andratschke N, Belka C, Corradini S, Marschner S, Liermann J, Horner-Rieber J, Fink C, Debus J, Silvia F, Tanadini-Lang S, Pouymayou B, Mencarelli A, Fesslmeier D, Schiess A, Guckenberger M, Mayinger M. Online adaptive stereotactic body radiotherapy for localized prostate cancer in patients with lower urinary tract symptoms and/or prostate hyperplasia (X-SMILE). Radiat Oncol. 2025 May 28;20(1):90. doi: 10.1186/s13014-025-02653-4.
PubMed 40437508
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer in Patients With Lower Urinary Tract Symptoms and/or Prostate Hyperplasia (X-SMILE)
- ClinicalTrials.gov ID
- NCT06834152
- Acronym / sponsor ID
- X-SMILE / RAO-24-014
- Conditions
- Localized Prostate Carcinoma, Prostate Cancer (Adenocarcinoma), Prostate Hyperplasia, Lower Urinary Track Symptoms
- Keywords
- radiotherapy, SBRT, MRI, CT, stereotactic radiotherapy, localized prostate cancer, lower urinary tract symptoms, prostate hyperplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Stereotactic body radiotherapy (SBRT) for localized prostate cancer has demonstrated non-inferior oncological outcomes and toxicity profiles to conventionally or moderately hypofractioned radiotherapy regimens, while offering the advantage of shorter treatment durations. However, SBRT may not be suitable for all patients, particularly those with lower urogenital tract symptoms and/or prostatic hyperplasia.
Methods: This study aims to evaluate the safety and efficacy of weekly computed tomography (CT) or magnetic resonance image-guided (MRI) online adaptive SBRT in patients with intermediate to (very) high-risk localized prostate cancer who present with lower urinary tract symptoms (International Prostate Symptom Score [IPSS] > 12) and/or have prostate hyperplasia (prostate volume >60 mL). The primary outcome measure is urogenital toxicity grade ≥3 within 3 months after completion of SBRT (according to CTCAE V5.0 and RTOG) or discontinuation of therapy. Our aim is to show that the event rate is at 3% below a clinically acceptable threshold, which is set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30. In our validation cohort we assume that around 3% of patients will have grade 3 long-term urogenital toxicity (i.e. 2 patients). The rate of treatment discontinuation within 3 months is considered negligible. Our aim is to show with high probability, that the event rate is below a clinically acceptable threshold, which is set at 12%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 75.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot study | – | Radiation: radiotherapyFor our pilot study, we assumed that around 3% of patients would have grade 3 acute urogenital toxicity (i.e. 1 patient). The rate of treatment discontinuation within 3 months was considered negligible. Our aim was to show with high probability, that the event rate was below a clinically acceptable threshold, which was set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30. Dropouts prior to treatment start will be replaced. |
| Validation Cohort | – | Radiation: radiotherapyFor our validation study, we assume that around 3% of patients will have grade 3 long-term urogenital toxicity (i.e. 2 patients). The rate of treatment discontinuation within 3 months is considered negligible. Our aim is to show with high probability, that the event rate is below a clinically acceptable threshold, which is set at 12%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 75. Dropouts prior to treatment start will be replaced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This international multicenter prospective phase II study, conducted in collaboration with several academic hospitals in Switzerland and Germany, will include patients with histologically confirmed intermediate to (very) high risk localized prostate cancer with lower urinary tract symptoms and/or prostate hyperplasia. These patients are planned to receive weekly CT or MRI online adaptive SBRT for localized prostate cancer.
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (6 listed)
- Very high risk localized prostate cancer with indication for ADT and ARPI (i.e. Gleason ≥ 8 and cT3a)
- Involvement of seminal vesicles (cT3b)
- 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;
- Patients with severe genitourinary symptoms (e.g. recent urinary retention ≥ grade 3 according CTCAE v.5.0);
- Lymph node metastases or distant metastases (i.e. no localised prostate cancer);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapyPatients with prostate cancer in the medium or high risk range who are planned to receive definitive CT or MRI-adaptive SBRT. | Radiation | Pilot study, Validation Cohort |
Primary outcome
acute grade ≥ III urogenital toxicity
Time frame: ≤ 3 months after completion of radiotherapy
The primary endpoint is acute grade ≥ III urogenital toxicity ≤3 months after completion of radiotherapy (according to the NCI CTCAE V5 or RTOG) or treatment discontinuation related to treatment.
9 secondary outcomes
Gastrointestinal toxicity of grade ≥3
Time frame: ≤ 3 months after completion of radiotherapy
Mortality
Time frame: ≤1 year after initiation of radiotherapy
Urogenital and gastrointestinal toxicities
Time frame: ≤ 5 years after completion of radiotherapy
Biochemical progression-free survival
Time frame: ≤ 5 years after completion of radiotherapy
Hormonal therapy-free survival
Time frame: ≤ 5 years after completion of radiotherapy
Overall survival
Time frame: 5 years after completion of radiotherapy
Quality-of-life questionnaire C-30 from the European Organisation for Research and Treatment of Cancer
Time frame: ≤ 5 years after completion of radiotherapy
Uroflowmetry (optional)
Time frame: Uroflowmetry ≤ 6 weeks prior to the start of radiotherapy
Quality-of-life questionnaire PR25 of the European Organisation for Research and Treatment of Cancer
Time frame: ≤ 5 years after completion of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 40437508Kroese T, Andratschke N, Belka C, Corradini S, Marschner S, Liermann J, Horner-Rieber J, Fink C, Debus J, Silvia F, Tanadini-Lang S, Pouymayou B, Mencarelli A, Fesslmeier D, Schiess A, Guckenberger M, Mayinger M. Online adaptive stereotactic body radiotherapy for localized prostate cancer in patients with lower urinary tract symptoms and/or prostate hyperplasia (X-SMILE). Radiat Oncol. 2025 May 28;20(1):90. doi: 10.1186/s13014-025-02653-4.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this trial after de-identification. Other documents may be shared include the study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Guckenberger, Prof. Dr. med. study chair
University of Zurich
Tiuri E. Kroese, MD, PhD principal investigator
University of Zurich
Matthias Guckenberger principal investigator
University of Zurich
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Localized Prostate Carcinoma and Prostate Cancer (Adenocarcinoma), run by University of Zurich at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radiation Oncology Study Office (+41442554108, RAO_akademischesoffice@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute grade ≥ III urogenital toxicity (time frame: ≤ 3 months after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06834152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.