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Study of MR-based IGRT for Prostate Cancer (M-basePro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02724670
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Arndt-Christian Mueller, University Hospital Tuebingen

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: IGRT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-arm Phase II Study of MR(Magnetic Resonance Imaging)-Based Image-guided Radiotherapy for Prostate Cancer
Study Start Date : March 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Radiation
IGRT 5x 2Gy/week, total dose: 78 Gy
Radiation: IGRT
MR-based IGRT




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724670


Contacts
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Contact: Arndt-Christian Müller, Dr. 497071/2986142 Arndt-Christian.Mueller@med.uni-tuebingen.de
Contact: Daniel Zips, Prof. 497071/2982165 Daniel.Zips@med.uni-tuebingen.de

Locations
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Germany
Müller Arndt-Christian Recruiting
Tübingen, Germany, 72076
Contact: Arndt-Christian Müller    070712986143    arndt-christian.mueller@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Arndt-Christian Müller, Dr. Department of Radiation Oncology, University of Tübingen
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Responsible Party: Arndt-Christian Mueller, PD Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02724670    
Other Study ID Numbers: M-base Pro 1.0
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases