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ACTIVE NOT RECRUITING
NCT04845503
NA

Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

Sponsor: University Hospital Heidelberg

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2021-03-25

Completion Date

2028-03-25

Last Updated

2026-03-10

Healthy Volunteers

No

Conditions

Interventions

RADIATION

MR-guided Radiotherapy

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

Locations (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, Germany