Study of MR-based IGRT for Prostate Cancer
Not Applicable
Recruiting
- Conditions
- Prostate Cancer
- Interventions
- Radiation: IGRT
- Registration Number
- NCT02724670
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with prostate carcinoma.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 78
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiation IGRT IGRT 5x 2Gy/week, total dose: 78 Gy
- Primary Outcome Measures
Name Time Method G2+gastrointestinal and genitourinary toxicity at 2 years Total trial treatment duration: 4 years, Duration for individual patient:Study treatment 9 months, Follow-up: 2 years for primary endpoint Number of participants with G2+-treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 2 years
- Secondary Outcome Measures
Name Time Method Long-term GU-GI toxicity 10 years after treatment Measurement of treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 10 years
Trial Locations
- Locations (1)
Müller Arndt-Christian
🇩🇪Tübingen, Germany