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.|
|ClinicalTrials.gov Identifier: NCT03880851|
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes||Not Applicable|
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
|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)|
|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|
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.
- 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%
- 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
- 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
- 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
- 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
- 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
- Time without secondary treatment "TWIST" [ Time Frame: 2, 5, 10 years ]Time without secondary treatment calculated from start of IGRT
- CTC-Proctitis [ Time Frame: 2, 5, 10 years ]CTC 4.0
- CTC-Incontinence [ Time Frame: 2, 5, 10 years ]CTC 4.0
- 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
- Overall survival "OS" [ Time Frame: 2, 5, 10 years ]Overall survival is calculated from start of IGRT
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): NCT03880851
|Contact: Silke Thedenfirstname.lastname@example.org|
|Contact: Arndt-Christian Müller|
|Tübingen, Germany, 72076|
|Contact: Arndt-Christian Müller 070712986143 email@example.com|