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NCT Number: NCT04845503

Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR-guided Radiotherapy

Radiation

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

Primary outcomes

  1. Toxicity or Discontinuation of Therapy

    Time frame: 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

Secondary outcomes

  1. Mortality

    Time frame: Within 1 year and within 5 years

    Mortality due to study treatment or due to prostate Cancer (Number of Participants deceased)

  2. Number of Toxicities

    Time frame: Within 1 year and within 5 years after start of radiotherapy

    Number and severity of urogenital or gastrointestinal toxicity

  3. bPFS

    Time frame: 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

    biochemical progression free survival

  4. Hormone therapy-free Survival

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

    Hormone therapy-free Survival

  5. OS

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

    overall survival

  6. Quality of life according to EORTC QLQ-C30

    Time frame: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)

    Quality of life according to EORTC QLQ-C30

  7. Quality of life according to EORTC QLQ-PR25

    Time frame: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)

    Quality of life according to EORTC QLQ-PR25

  8. Symptoms and Toxicity

    Time frame: from start of radiotherapy (day 1) until end of follow-up (up to 5 years)

    Symptoms and Toxicity according to NCI CTCAE (Rate)

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Ludwig-Maximilians - University of Munich
  • University Hospital, Zürich

Registry information

Acronym: SMILE

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Apr 15, 2021
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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