Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

NCT04845503 | Active Not Recruiting

• 1 other identifier: SMILE
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Toxicity or Discontinuation of Therapy

  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

  Within 1 Year

Secondary Outcomes (8)

• Mortality

  Within 1 year and within 5 years

• Number of Toxicities

  Within 1 year and within 5 years after start of radiotherapy

• bPFS

  from start of radiotherapy (day 1) until PSA-relapse according to Phoenix-Criteria (Prostate-specific antigen (PSA) nadir + 2 ng/mL after radiotherapy), assessed up to 5 years

• Hormone therapy-free Survival

  from start of radiotherapy until start of hormon treatment; maximum 3 months neoadjuvant

• OS

  from start of radiotherapy (day 1) until death or censoring assessed up to 5 years

Study Arms (1)

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

EXPERIMENTAL

5 x 7,5 Gy prescribed on the PTV

Radiation: MR-guided Radiotherapy

Interventions

MR-guided Radiotherapy RADIATION

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: collaborator
• University Hospital, Zürich: collaborator
• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director RadioOncology

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: April 15, 2021
• Study Start: March 25, 2021
• Primary Completion: March 25, 2023
• Study Completion (Estimated): March 25, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

DE (1)