Study of MR-based IGRT for Prostate Cancer

Overview

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

Full Title of Study: “Single-arm Phase II Study of MR(Magnetic Resonance Imaging)-Based Image-guided Radiotherapy for Prostate Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2020

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

Arms, Groups and Cohorts

  • Other: Radiation
    • IGRT 5x 2Gy/week, total dose: 78 Gy

Clinical Trial Outcome Measures

Primary 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
    • Number of participants with G2+-treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 2 years

Secondary Measures

  • Long-term GU-GI toxicity
    • Time Frame: 10 years after treatment
    • Measurement of treatment-related genitournary and gastrointestinal adverse events assessed by CTCAE v4.0 and RTOG at 10 years

Participating in This Clinical Trial

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)

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Tuebingen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Arndt-Christian Mueller, PD Dr. med. – University Hospital Tuebingen
  • Overall Official(s)
    • Arndt-Christian Müller, Dr., Principal Investigator, Department of Radiation Oncology, University of Tübingen
  • Overall Contact(s)
    • Arndt-Christian Müller, Dr., 497071/2986142, Arndt-Christian.Mueller@med.uni-tuebingen.de

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