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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Plan adaptation of Radiation Treatment in case of anatomical changes
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring hypofractionation, MR-based IGRT, Mbase HyPro

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Müller Arndt-ChristianRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hypofractionated image-guided radiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT
Feasibility and tolerability of completing at least 2 of 4 MRIs during treatment
Rate of participants achieving local control
In case of PSA progress: No evidence of local recurrence detected by MRI
Rate of participants achieving regional control
In case of PSA progress: No evidence of regional recurrence detected by MRI
Rate of participants achieving Distant-metastasis-free survival "DMFS"
No evidence of distant metastases diagnosed by cross-sectional imaging including bone scan, MRI, CT and PET
Number of Participants with biochemical no evidence of disease "bNED"
biochemical no evidence of disease according to Phoenix definition: nadir + 2ng/ml
Time without secondary treatment "TWIST"
Time without secondary treatment calculated from start of IGRT
CTC-Proctitis
CTC 4.0
CTC-Incontinence
CTC 4.0
Progression-free survival "PFS"
progression-free survival is defined as any progression (biochemical or other recurrences) or death or initiation of secondary treatment, calculation from start of IGRT
Overall survival "OS"
Overall survival is calculated from start of IGRT

Full Information

First Posted
February 11, 2019
Last Updated
March 18, 2019
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT03880851
Brief Title
MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0)
Acronym
Mbase_HyPro
Official Title
Single-arm Phase (II) Study on MR-based Hypofractionated Adaptive Image-guided Radiation Therapy for Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
hypofractionation, MR-based IGRT, Mbase HyPro

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypofractionated image-guided radiotherapy
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Plan adaptation of Radiation Treatment in case of anatomical changes
Intervention Description
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 Measure Information:
Title
Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2
Description
Hypothesis: reduction of GI/GU-toxicity (CTC-criteria 4.0, RTOG) from 20% to 10% at 2 years, power 80%
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT
Description
Feasibility and tolerability of completing at least 2 of 4 MRIs during treatment
Time Frame
6 months
Title
Rate of participants achieving local control
Description
In case of PSA progress: No evidence of local recurrence detected by MRI
Time Frame
2, 5, 10 years
Title
Rate of participants achieving regional control
Description
In case of PSA progress: No evidence of regional recurrence detected by MRI
Time Frame
2, 5, 10 years
Title
Rate of participants achieving Distant-metastasis-free survival "DMFS"
Description
No evidence of distant metastases diagnosed by cross-sectional imaging including bone scan, MRI, CT and PET
Time Frame
2, 5, 10 years
Title
Number of Participants with biochemical no evidence of disease "bNED"
Description
biochemical no evidence of disease according to Phoenix definition: nadir + 2ng/ml
Time Frame
2, 5, 10 years
Title
Time without secondary treatment "TWIST"
Description
Time without secondary treatment calculated from start of IGRT
Time Frame
2, 5, 10 years
Title
CTC-Proctitis
Description
CTC 4.0
Time Frame
2, 5, 10 years
Title
CTC-Incontinence
Description
CTC 4.0
Time Frame
2, 5, 10 years
Title
Progression-free survival "PFS"
Description
progression-free survival is defined as any progression (biochemical or other recurrences) or death or initiation of secondary treatment, calculation from start of IGRT
Time Frame
2, 5, 10 years
Title
Overall survival "OS"
Description
Overall survival is calculated from start of IGRT
Time Frame
2, 5, 10 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silke Theden
Phone
+49707183420
Email
silke.theden@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Arndt-Christian Müller
Facility Information:
Facility Name
Müller Arndt-Christian
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arndt-Christian Müller
Phone
070712986143
Email
arndt-christian.mueller@med.uni-tuebingen.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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