Study of MR-based IGRT for Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IGRT.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Single-arm Phase II Study of MR(Magnetic Resonance Imaging)-Based Image-guided Radiotherapy for Prostate Cancer
Overview
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.
Interventions
- Radiation IGRT
MR-based IGRT
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Long-term GU-GI toxicity [Time frame: 10 years after treatment]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Müller Arndt-Christian — Tübingen
Identifiers
NCT: NCT02724670 · M-base Pro 1.0