Study of MR-based IGRT for Prostate Cancer
This trial is active, not recruiting.
|Sponsor||University Hospital Tuebingen|
|Start date||March 2016|
|End date||June 2020|
|Trial size||78 participants|
|Trial identifier||NCT02724670, M-base Pro 1.0|
MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with prostate carcinoma.
|Intervention model||single group assignment|
IGRT 5x 2Gy/week, total dose: 78 Gy
G2+gastrointestinal and genitourinary toxicity at 2 years
time frame: Total trial treatment duration: 4 years, Duration for individual patient:Study treatment 9 months, Follow-up: 2 years for primary endpoint
Long-term GU-GI toxicity
time frame: 10 years after treatment
Male participants at least 18 years old.
Inclusion Criteria: - histologically proven prostate cancer - indication for curative treatment - ECOG performance scale 0-2 - Informed consent Exclusion Criteria: - contraindications for curative treatment - age<18year - previous pelvic radiotherapy or prostatic treatment like TURP (transurethral resection of prostate), HIFU (high intensity focused ultrasound) - serious comorbidity leading to inability for IGRT (image-guided radiotherapy) - contraindications for MRI (Magnetic Resonance Imaging)
|Official title||Single-arm Phase II Study of MR(Magnetic Resonance Imaging)-Based Image-guided Radiotherapy for Prostate Cancer|
|Principal investigator||Arndt-Christian Müller, Dr.|
|Description||Single arm, phase II study, MR (Magnetic Resonance Imaging) - based IGRT (Image-guided radiotherapy) of prostate cancer. Primary endpoint: Grade 2+ GI (gastrointestinal) and genitourinary (GU) toxicity after 2 years.|
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