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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated image-guided radiotherapy | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plan adaptation of Radiation Treatment in case of anatomical changes | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Rate of participants achieving local control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silke Theden | Contact | +49707183420 | silke.theden@med.uni-tuebingen.de | |
| Arndt-Christian Müller | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Müller Arndt-Christian | Recruiting | Tübingen | 72076 | Germany |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Phase II, Intervention: Plan adaption in case of significant changes of organ at risk or target volumes measured in weekly MRIs
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In case of PSA progress: No evidence of local recurrence detected by MRI
| 2, 5, 10 years |
| Rate of participants achieving regional control | In case of PSA progress: No evidence of regional recurrence detected by MRI | 2, 5, 10 years |
| 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 | 2, 5, 10 years |
| Number of Participants with biochemical no evidence of disease "bNED" | biochemical no evidence of disease according to Phoenix definition: nadir + 2ng/ml | 2, 5, 10 years |
| Time without secondary treatment "TWIST" | Time without secondary treatment calculated from start of IGRT | 2, 5, 10 years |
| CTC-Proctitis | CTC 4.0 | 2, 5, 10 years |
| CTC-Incontinence | CTC 4.0 | 2, 5, 10 years |
| 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 | 2, 5, 10 years |
| Overall survival "OS" | Overall survival is calculated from start of IGRT | 2, 5, 10 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |