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MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0) (Mbase_HyPro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03880851
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 20, 2019
Information provided by (Responsible Party):
Arndt-Christian Mueller, University Hospital Tuebingen

Brief Summary:
Single-centre single-armed, non-randomized interventional phase II-study of hypofractionated image-guided radiotherapy "IGRT" with weekly magnetic resonance imagings "MRI" for personalized adaptation of the treatment plan depending on individual MR-anatomy of prostate/organ at risks "OAR" during course of IGRT.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes Not Applicable

Detailed Description:

IGRT-schedule: 20 fractions to a total dose of 60 Gy

Personalized adaption of treatment plan dependning on volume-/ and constraint-thresholds and evaluation of biomarkers (multiparametric MRI, blood, tissue, stool, urine).

Treatment at MR-Linac allowed

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Phase II, Intervention: Plan adaption in case of significant changes of organ at risk or target volumes measured in weekly MRIs
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-arm Phase (II) Study on MR-based Hypofractionated Adaptive Image-guided Radiation Therapy for Prostate Cancer
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Hypofractionated image-guided radiotherapy

Hypofractionated image-guided radiotherapy "IGRT" to a total dose of 60 Gy (20 fractions) is performed.

Weekly MRI are used to estimate volume/deformation changes of OAR and target volume.

Intervention: In case of a significant change of target volume or OARs (threshold based) the radiation treatment plan is adapted on individual MR-anatomy.

Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes
Image guided radiotherapy is given to 60Gy in 20 fractions. Intervention: Radiation treatment plan adaption in case of volume changes of target volume or not meeting OAR constraints due to volume changes.

Primary Outcome Measures :
  1. Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2 [ Time Frame: 2 years ]
    Hypothesis: reduction of GI/GU-toxicity (CTC-criteria 4.0, RTOG) from 20% to 10% at 2 years, power 80%

Secondary Outcome Measures :
  1. Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT [ Time Frame: 6 months ]
    Feasibility and tolerability of completing at least 2 of 4 MRIs during treatment

  2. Rate of participants achieving local control [ Time Frame: 2, 5, 10 years ]
    In case of PSA progress: No evidence of local recurrence detected by MRI

  3. Rate of participants achieving regional control [ Time Frame: 2, 5, 10 years ]
    In case of PSA progress: No evidence of regional recurrence detected by MRI

  4. Rate of participants achieving Distant-metastasis-free survival "DMFS" [ Time Frame: 2, 5, 10 years ]
    No evidence of distant metastases diagnosed by cross-sectional imaging including bone scan, MRI, CT and PET

  5. Number of Participants with biochemical no evidence of disease "bNED" [ Time Frame: 2, 5, 10 years ]
    biochemical no evidence of disease according to Phoenix definition: nadir + 2ng/ml

  6. Time without secondary treatment "TWIST" [ Time Frame: 2, 5, 10 years ]
    Time without secondary treatment calculated from start of IGRT

  7. CTC-Proctitis [ Time Frame: 2, 5, 10 years ]
    CTC 4.0

  8. CTC-Incontinence [ Time Frame: 2, 5, 10 years ]
    CTC 4.0

  9. Progression-free survival "PFS" [ Time Frame: 2, 5, 10 years ]
    progression-free survival is defined as any progression (biochemical or other recurrences) or death or initiation of secondary treatment, calculation from start of IGRT

  10. Overall survival "OS" [ Time Frame: 2, 5, 10 years ]
    Overall survival is calculated from start of IGRT

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • biopsy-proven prostate cancer with indication for RT
  • cT1b-cT3a cN0 cM0
  • ECOG Performance score 0-2
  • IPSS≤12 (before planning computed tomography i.e. reached after neoadjuvant androgen deprivation therapy or tamsulosin)
  • age>18 years
  • Informed consent

Exclusion Criteria:

  • not fulfilled inclusion criteria
  • contraindication against curative RT
  • age<18 years
  • previous pelvic radiotherapy or planned pelvic radiotherapy
  • comorbidities interfering with image-guided radiotherapy
  • contraindications against multiparametric MRI (like hio prosthesis, pacer, allergy against contrast media)
  • prior transurethral resection, highly focussed ultrasound or other pre-treatment of prostate

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 identifier (NCT number): NCT03880851

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Contact: Silke Theden +49707183420
Contact: Arndt-Christian Müller

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Müller Arndt-Christian Recruiting
Tübingen, Germany, 72076
Contact: Arndt-Christian Müller    070712986143   
Sponsors and Collaborators
University Hospital Tuebingen

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Responsible Party: Arndt-Christian Mueller, Deputy Head of the Department of Radiation Oncology, University Hospital Tuebingen Identifier: NCT03880851     History of Changes
Other Study ID Numbers: Mbase HyPro 2.0
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arndt-Christian Mueller, University Hospital Tuebingen:
MR-based IGRT
Mbase HyPro

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases