Prostate CancerSMILENCT04845503
Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer
A study testing MR-guided Radiotherapy in people with Prostate Cancer, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
As the most common carcinoma in men, prostate cancer is a significant tumor entity in oncology. In addition to the surgical approach, definitive radiotherapy is an equivalent therapy alternative in the non-metastatic primary situation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MR-guided Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 25 Mar 2021to 25 Mar 2028
- Phase
- Interventional
- 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
Who may be able to join
- Histologically confirmed prostate carcinoma with tissue classification according to Gleason score and PSA
- low- or intermediate-risk carcinoma according to d'Amico criteria or early high-risk Carcinoma (cT3a and / or GS ≤ 8 and / or PSA ≤ 20ng / ml)
- IPSS (International Prostate Symptom Score) max. 12
- Prostate volume <80cm³
- Karnofsky index ≥ 70%
- Age ≥ 18 years
- Patient information provided and written consent
- Ability of the patient to give consent
Who cannot join
- Previous radiotherapy in the pelvis
- Previous local therapy of the prostate
- lymphogenic metastasis
- Stage IV (distant metastases)
- Contraindication to MRI
- Simultaneous participation in another clinical study which could influence results of either of the respective study
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120
About this study
As the most common carcinoma in men, prostate cancer is a significant tumor entity in oncology. In addition to the surgical approach, definitive radiotherapy is an equivalent therapy alternative in the non-metastatic primary situation. However, radiotherapy usually stretches over a period of several weeks (7 to 8 weeks) during which the patient receives irradiation on a daily basis. For this reason and for radiobiological considerations the total treatment time is increasingly shortened. It has been shown in several randomized phase III studies that shorting radiotherapy to about 4 weeks by increasing the single dose (so-called hypofractionation) is possible. Meanwhile there is also more data on extreme hypofractionation (max. 10 radiation sessions) available, however often times, extensive preparations are necessary (such as the invasive introduction of markers into the prostate). The current, prospective, non-randomized, multicentric, Phase II SMILE study is now testing whether the MRI-guided radiotherapy with a greatly shortened radiotherapy of the prostate over 5 radiation sessions is possible and safe.
- Conditions
- Prostate Cancer
- Being tested
- MR-guided Radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided RadiotherapyRadiation
Total Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks
| Study group | Role | What they receive |
|---|---|---|
| MR-guided Radiotherapy (5 x 7,5 Gy) | Experimental | 5 x 7,5 Gy prescribed on the PTV Receives: Radiation: MR-guided Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity or Discontinuation of Therapy
One of the the following events are counted as an Event (Number of Participants affected):
- any urogenital or gastrointestinal grade ≥ 2 toxicity within one year after the start of RT (according to NCI CTCAE Version 5.0)
- Discontinuation of therapy, with a connection to the study treatment
Measured: Within 1 Year
Secondary outcomes (8)
Mortality
Mortality due to study treatment or due to prostate Cancer (Number of Participants deceased)
Measured: Within 1 year and within 5 years
Number of Toxicities
Number and severity of urogenital or gastrointestinal toxicity
Measured: Within 1 year and within 5 years after start of radiotherapy
bPFS
biochemical progression free survival
Measured: from start of radiotherapy (day 1) until PSA-relapse according to Phoenix-Criteria (Prostate-specific antigen (PSA) nadir + 2 ng/mL after radiotherapy), assessed up to 5 years
Hormone therapy-free Survival
Hormone therapy-free Survival
Measured: from start of radiotherapy until start of hormon treatment; maximum 3 months neoadjuvant
OS
overall survival
Measured: from start of radiotherapy (day 1) until death or censoring assessed up to 5 years
Quality of life according to EORTC QLQ-C30
Quality of life according to EORTC QLQ-C30
Measured: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)
Quality of life according to EORTC QLQ-PR25
Quality of life according to EORTC QLQ-PR25
Measured: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)
Symptoms and Toxicity
Symptoms and Toxicity according to NCI CTCAE (Rate)
Measured: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start25 Mar 2021
- Primary completion25 Mar 2023
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Hospital, Zürich
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845503
- Sponsor's protocol ID
- SMILE
- Acronym
- SMILE
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer
- ClinicalTrials.gov ID
- NCT04845503
- Acronym / sponsor ID
- SMILE / SMILE
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Hospital, Zürich
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 15 Apr 2021 (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.
As the most common carcinoma in men, prostate cancer is a significant tumor entity in oncology. In addition to the surgical approach, definitive radiotherapy is an equivalent therapy alternative in the non-metastatic primary situation. However, radiotherapy usually stretches over a period of several weeks (7 to 8 weeks) during which the patient receives irradiation on a daily basis. For this reason and for radiobiological considerations the total treatment time is increasingly shortened. It has been shown in several randomized phase III studies that shorting radiotherapy to about 4 weeks by increasing the single dose (so-called hypofractionation) is possible. Meanwhile there is also more data on extreme hypofractionation (max. 10 radiation sessions) available, however often times, extensive preparations are necessary (such as the invasive introduction of markers into the prostate). The current, prospective, non-randomized, multicentric, Phase II SMILE study is now testing whether the MRI-guided radiotherapy with a greatly shortened radiotherapy of the prostate over 5 radiation sessions is possible and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-guided Radiotherapy (5 x 7,5 Gy) | Experimental | Radiation: MR-guided Radiotherapy5 x 7,5 Gy prescribed on the PTV |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed prostate carcinoma with tissue classification according to Gleason score and PSA
- low- or intermediate-risk carcinoma according to d'Amico criteria or early high-risk Carcinoma (cT3a and / or GS ≤ 8 and / or PSA ≤ 20ng / ml)
- IPSS (International Prostate Symptom Score) max. 12
- Prostate volume <80cm³
- Karnofsky index ≥ 70%
Key exclusion criteria (6 listed)
- Previous radiotherapy in the pelvis
- Previous local therapy of the prostate
- lymphogenic metastasis
- Stage IV (distant metastases)
- Contraindication to MRI
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 |
|---|---|---|
| MR-guided RadiotherapyTotal Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks | Radiation | MR-guided Radiotherapy (5 x 7,5 Gy) |
Primary outcome
Toxicity or Discontinuation of Therapy
Time frame: Within 1 Year
One of the the following events are counted as an Event (Number of Participants affected): * any urogenital or gastrointestinal grade ≥ 2 toxicity within one year after the start of RT (according to NCI CTCAE Version 5.0) * Discontinuation of therapy, with a connection to the study treatment
8 secondary outcomes
Mortality
Time frame: Within 1 year and within 5 years
Number of Toxicities
Time frame: Within 1 year and within 5 years after start of radiotherapy
bPFS
Time frame: from start of radiotherapy (day 1) until PSA-relapse according to Phoenix-Criteria (Prostate-specific antigen (PSA) nadir + 2 ng/mL after radiotherapy), assessed up to 5 years
Hormone therapy-free Survival
Time frame: from start of radiotherapy until start of hormon treatment; maximum 3 months neoadjuvant
OS
Time frame: from start of radiotherapy (day 1) until death or censoring assessed up to 5 years
Quality of life according to EORTC QLQ-C30
Time frame: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)
Quality of life according to EORTC QLQ-PR25
Time frame: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)
Symptoms and Toxicity
Time frame: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)
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 10 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-guided Radiotherapy in people with Prostate Cancer, run by University Hospital Heidelberg at 1 site in Germany.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity or Discontinuation of Therapy (time frame: Within 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2026.