Study of MR-based IGRT for Prostate Cancer

University Hospital Tuebingen78 enrolled

Overview

MR (Magnetic Resonance Imaging) - based IGRT (image-guided radiotherapy) for patients with prostate carcinoma.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

IGRTRADIATION

MR-based IGRT

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Müller Arndt-Christian

Tübingen, Germany

RECRUITING

Outcomes

Primary Outcomes

G2+gastrointestinal and genitourinary toxicity at 2 years

Number of participants with G2+-treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG 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

Measurement of treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 10 years

Time frame: 10 years after treatment

Central Contacts

Arndt-Christian Müller, Dr.

CONTACT

497071/2986142 Arndt-Christian.Mueller@med.uni-tuebingen.de

Daniel Zips, Prof.

CONTACT

497071/2982165 Daniel.Zips@med.uni-tuebingen.de

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.