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Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer (SMILE)

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ClinicalTrials.gov Identifier: NCT04845503
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich
University Hospital, Zürich
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: MR-guided Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic MRI-guided Radiation Therapy for Localized prostatE Cancer
Actual Study Start Date : March 25, 2021
Estimated Primary Completion Date : March 25, 2023
Estimated Study Completion Date : March 25, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: MR-guided Radiotherapy (5 x 7,5 Gy)
5 x 7,5 Gy prescribed on the PTV
Radiation: MR-guided Radiotherapy
Total Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04845503


Locations
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Germany
University Hospital of Heidelberg, Radiation Oncology Recruiting
Heidelberg, Germany, 69120
Contact: Stefan Körber, PD Dr.    +496221568202    Studien.Radonk@med.uni-heidelberg.de   
Principal Investigator: Stefan Körber, PD Dr.         
Sponsors and Collaborators
University Hospital Heidelberg
Ludwig-Maximilians - University of Munich
University Hospital, Zürich
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Responsible Party: Juergen Debus, Medical Director RadioOncology, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04845503    
Other Study ID Numbers: SMILE
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases