NCT04845503Active, not recruiting
Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 5 Mar 2021
- Start date
- 25 Mar 2021
- Primary completion date
- 25 Mar 2023
- Lead sponsor
- University Hospital Heidelberg
- Diseases
- Prostate cancer
- NCT number
- NCT04845503
What you commit to
- Study type: Interventional
- Planned participants: 68
- From 25 Mar 2021 to the primary completion date, 25 Mar 2023
- 1 site in 1 country
- 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
- Previous radiotherapy in the pelvis
- Previous local therapy of the prostate
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Heidelberg, Radiation Oncology Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.