Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

NCT ID: NCT04845503

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-25
• Study Completion Date: 2028-03-25

Brief 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

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MR-guided Radiotherapy (5 x 7,5 Gy)

5 x 7,5 Gy prescribed on the PTV

Group Type: EXPERIMENTAL

MR-guided Radiotherapy

Intervention Type: RADIATION

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

Interventions

MR-guided Radiotherapy

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: collaborator

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Juergen Debus

Medical Director RadioOncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, , Germany

Countries

Germany

Other Identifiers

SMILE

Identifier Type: -

Identifier Source: org_study_id