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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
IGRT
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Müller Arndt-ChristianRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radiation

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2016
Last Updated
September 23, 2019
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT02724670
Brief Title
Study of MR-based IGRT for Prostate Cancer
Acronym
M-basePro
Official Title
Single-arm Phase II Study of MR(Magnetic Resonance Imaging)-Based Image-guided Radiotherapy for Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Recruiting
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiation
Arm Type
Other
Arm Description
IGRT 5x 2Gy/week, total dose: 78 Gy
Intervention Type
Radiation
Intervention Name(s)
IGRT
Intervention Description
MR-based IGRT
Primary Outcome Measure Information:
Title
G2+gastrointestinal and genitourinary toxicity at 2 years
Description
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 Outcome Measure Information:
Title
Long-term GU-GI toxicity
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arndt-Christian Müller, Dr.
Phone
497071/2986142
Email
Arndt-Christian.Mueller@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Zips, Prof.
Phone
497071/2982165
Email
Daniel.Zips@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arndt-Christian Müller, Dr.
Organizational Affiliation
Department of Radiation Oncology, University of Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Müller Arndt-Christian
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arndt-Christian Müller
Phone
070712986143
Email
arndt-christian.mueller@med.uni-tuebingen.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of MR-based IGRT for Prostate Cancer

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