Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

MR-guided Radiotherapy: Total Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks

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.

Eligibility

Primary outcome measure(s)

• Toxicity or Discontinuation of Therapy — 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

Trial sites (1)

More University Hospital Heidelberg trials in Germany

Other trials for the same condition