This trial is active, not recruiting.

Condition prostate cancer
Treatment igrt
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
IGRT 5x 2Gy/week, total dose: 78 Gy
MR-based IGRT

Primary Outcomes

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 Outcomes

Long-term GU-GI toxicity
time frame: 10 years after treatment

Eligibility Criteria

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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.