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Status unknownNCT03880851Mbase_HyProUpdated Mar 20, 2019

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

An interventional study of Plan adaptation of Radiation Treatment in case of anatomical changes in Prostate Cancer, sponsored by University Hospital Tuebingen. Status unknown at 1 site in Germany. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
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Study 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.

Read the 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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Conditions studied

  • Prostate Cancer

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Keywords

  • hypofractionation
  • MR-based IGRT
  • Mbase HyPro
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 78 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Other
    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

Interventions

  • RadiationPlan 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.

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What researchers measure

Primary outcomes

  1. 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%

    Time frame: 2 years

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. Rate of participants achieving local control

    In case of PSA progress: No evidence of local recurrence detected by MRI

    Time frame: 2, 5, 10 years

  3. Rate of participants achieving regional control

    In case of PSA progress: No evidence of regional recurrence detected by MRI

    Time frame: 2, 5, 10 years

  4. 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

    Time frame: 2, 5, 10 years

  5. Number of Participants with biochemical no evidence of disease "bNED"

    biochemical no evidence of disease according to Phoenix definition: nadir + 2ng/ml

    Time frame: 2, 5, 10 years

  6. Time without secondary treatment "TWIST"

    Time without secondary treatment calculated from start of IGRT

    Time frame: 2, 5, 10 years

  7. CTC-Proctitis

    CTC 4.0

    Time frame: 2, 5, 10 years

  8. CTC-Incontinence

    CTC 4.0

    Time frame: 2, 5, 10 years

  9. 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

    Time frame: 2, 5, 10 years

  10. Overall survival "OS"

    Overall survival is calculated from start of IGRT

    Time frame: 2, 5, 10 years

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03880851
Lead sponsor
University Hospital Tuebingen
Responsible party
Arndt-Christian Mueller (Deputy Head of the Department of Radiation Oncology, University Hospital Tuebingen) — Principal investigator
First posted
Mar 19, 2019
Start date
Jan 23, 2019
Primary completion
Jan 31, 2024 (estimated)
Completion
Jan 31, 2024 (estimated)
Last update
Mar 20, 2019

Study contacts

Silke Theden
Contact
silke.theden@med.uni-tuebingen.de
+49707183420
Arndt-Christian Müller
Contact

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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