Study of MR-based IGRT for Prostate Cancer

NCT ID: NCT02724670

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2028-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiation

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

Group Type OTHER

IGRT

Intervention Type RADIATION

MR-based IGRT

Interventions

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IGRT

MR-based IGRT

Intervention Type RADIATION

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Arndt-Christian Mueller

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arndt-Christian Müller, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, University of Tübingen

Locations

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Müller Arndt-Christian

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Arndt-Christian Müller, Dr.

Role: CONTACT

497071/2986142

Daniel Zips, Prof.

Role: CONTACT

497071/2982165

Facility Contacts

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Arndt-Christian Müller

Role: primary

070712986143

Other Identifiers

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M-base Pro 1.0

Identifier Type: -

Identifier Source: org_study_id

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