MR-based image-guided radiotherapy for prostate cancer
Single-arm Phase II Study of MR(Magnetic Resonance Imaging)-Based Image-guided Radiotherapy for Prostate Cancer
This study is testing if using MRI during radiation therapy can make treatment safer and more effective for men with prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT02724670 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of Magnetic Resonance Imaging (MRI) for image-guided radiotherapy (IGRT) in patients diagnosed with prostate cancer. It is a single-arm, phase II study focusing on the effectiveness and safety of MRI-based IGRT. The primary endpoint is to assess the incidence of grade 2 or higher gastrointestinal and genitourinary toxicity after two years of treatment. The study aims to improve treatment precision and patient outcomes in prostate cancer management.
Who should consider this trial
Good fit: Ideal candidates include men with histologically proven prostate cancer who are eligible for curative treatment and have an ECOG performance scale of 0-2.
Not a fit: Patients with contraindications for MRI or those who have had previous pelvic radiotherapy or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced side effects and improved treatment outcomes for prostate cancer patients.
How similar studies have performed: Other studies have shown promise with MRI-based IGRT approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Tübingen
- Müller Arndt-Christian — Tübingen, Germany (Recruiting)
Study contacts
- Principal investigator: Arndt-Christian Müller, Dr. — Department of Radiation Oncology, University of Tübingen
- Study coordinator: Arndt-Christian Müller, Dr.
- Email: Arndt-Christian.Mueller@med.uni-tuebingen.de
- Phone: 497071/2986142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.