HistScanning- Based PDR Brachytherapy in Prostate Cancer HistoScanning- Based Interstitial PDR Brachytherapy
NCT ID: NCT01409876
Last Updated: 2011-08-04
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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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2011-09-30
2016-09-30
Brief Summary
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Endpoints:
Primary endpoint Evaluation of the feasibility of HistoScanning- based dose-painting image- guided interstitial brachytherapy
Secondary endpoints
1. Evaluating tumor response using HistoScanning
2. Evaluating locoregional recurrence rates by measuring PSA
3. Analysis of the correlation between tumor response as determined by HistoScanning and PSA response
4. Evaluating the safety dose-painting image- guided interstitial brachytherapy by recording serious adverse events
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Detailed Description
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The study is designed as a prospective monocentric phase II trial. The choice of the therapeutic concept is governed by the risk group that the patient falls into. Risk groups are defined according to the classification by D' Amico.
The following concepts will be used:
HDR brachytherapy: 19,0- 38 Gy / 2-4 fractions (2-4 x 9,5 Gy)
PDR brachytherapy: 35-70 Gy / 50 --100 pulses(1 puls/h, 24 h/d)
Dose painting the timorous areas as seen in HistoScanning as covered with a dose Dref2\>130-150%
External beam radiotherapy will be used in addition to brachytherapy for intermediate and high risk patients. The following concepts will be used 50,40 Gy / 28 fractions at 1.8 Gy
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brachytherapy
brachytherapy
interstitial image- guided PDR/HDR brachytherapy
Interventions
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brachytherapy
interstitial image- guided PDR/HDR brachytherapy
Eligibility Criteria
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Inclusion Criteria
* All cT1-3 carcinomas independent of grading and PSA value
* Prostate volume\< 70cc
* No distant metastases
* Karnofsky \> 60
* Written informed consent from the patient regarding study participation
* T4 carcinomas
* Proven metastases N+ and/or M1
* Epidural or general anaesthesia not possible
* Pathological clotting parameters
18 Years
MALE
No
Sponsors
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University Hospital Erlangen
OTHER
Responsible Party
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University Hospital Erlangen
Locations
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Department of Radiation Therapy University Hospital
Erlangen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Strnad V, Lotter M, Kreppner S, Fietkau R. Brachytherapy focal dose escalation using ultrasound based tissue characterization by patients with non-metastatic prostate cancer: Five-year results from single-center phase 2 trial. Brachytherapy. 2022 Jul-Aug;21(4):415-423. doi: 10.1016/j.brachy.2022.02.003. Epub 2022 Apr 6.
Other Identifiers
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HistoBrachy1
Identifier Type: -
Identifier Source: org_study_id
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