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Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

NCT04845503 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-03-10

No results posted yet for this study

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. 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

Interventions

RADIATION

MR-guided Radiotherapy

Total Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • University Hospital, Zürich

    collaborator OTHER

  • University Hospital Heidelberg

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2023-03-25
Completion
2028-03-25

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04845503 on ClinicalTrials.gov