Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial
NCT ID: NCT02391051
Last Updated: 2017-08-11
Study Results
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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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2014-10-31
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Focal Brachytherapy
HDR-Brachytherapy, 2 fractions within at least 24 but max. 30 hours, each 13,5 Gy
HDR-Brachytherapy
HDR-Brachytherapy 2x 13,5 Gy
Interventions
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HDR-Brachytherapy
HDR-Brachytherapy 2x 13,5 Gy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed prostate cancer
* Gleason Score of index lesion ≤ 6 (3+3)
* Tumor stage: cT1-2a cN0 cM0
* Unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. No more than 25% of the punch should be affected. Therefore a 3D-TPM-biopsy is mandatory before treatment.
* PSA ≤ 10/ng/ml
* Prostate volume \< 60 m\^3
* No distant metastasis
* Life expectancy \> 10 years
* Informed consent
Exclusion Criteria
* Known metastasis: N+ and/or M1
* General anesthesia or peridural anesthesia is not possible
* Coagulation disorder
18 Years
MALE
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Vratislav Strnad, MD
Role: STUDY_CHAIR
University Hospital Erlangen, Dept. of Radiooncology
Bastian Keck, MD
Role: STUDY_CHAIR
University Hospital Erlangen, Dept. of Urology
Alexander Cavallaro, MD
Role: STUDY_CHAIR
University Hospital Erlangen, Dept. of Radiology
Arndt Hartmann, MD
Role: STUDY_CHAIR
University Hospital Erlangen, Dept. of Pathology
Michael Lotter, Dipl.-Phys.
Role: STUDY_CHAIR
University Hospital Erlangen, Dept. of Radiooncology
Annedore Strnad, MD, MHBA
Role: STUDY_CHAIR
University Hospital Erlangen, Dept. of Radiooncology
Peter Goebell, MD
Role: STUDY_CHAIR
University Hospital Erlangen, Dept. of Urology
Wolfgang Uter, MD
Role: STUDY_CHAIR
University Erlangen; Dept. of Biometrics and Epidemiology
Michael Uder, MD
Role: STUDY_CHAIR
University Hospital Erlangen, Dept. of Radiology
Bernd Wullich, MD
Role: STUDY_CHAIR
University Hospital Erlangen, Dept. of Urology
Rainer Fietkau, MD
Role: STUDY_CHAIR
University Hospital Erlangen, Dept. of Radiooncology
Locations
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University Hospital
Erlangen, , Germany
Countries
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Facility Contacts
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Other Identifiers
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FOKAL-BT
Identifier Type: -
Identifier Source: org_study_id
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