Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer
NCT ID: NCT01039038
Last Updated: 2011-11-28
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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TERMINATED
PHASE2
50 participants
INTERVENTIONAL
2009-09-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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curietherapy and radiotherapy
boost of curietherapy(40 Gy)and external radiotherapy (34 Gy)
Eligibility Criteria
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Inclusion Criteria
* Life expectancy \>10 years
* Localized prostatic adenocarcinoma and histologically proven
* Intermediate risk cancer(T2b or PSA between 10 and 20 or Gleason = 7(3+4) according to Amico criteria
* Metastasis or pelvic pathologic ganglion (≥ 10 mm) absence
* OMS \< 2
* No previous treatment by radiotherapy and/or curietherapy
* Hormonotherapy authorized before and during the study
* Rectal or uretero-vesical pathology
* Signed informed consent
* Social security system affiliation
* Individual deprived of liberty or placed under the authority of a tutor.
* No anesthesia contraindication
Exclusion Criteria
* Metastases presence
* Pathological nodes presence(≥ 10 mm)
* Prior prostate endoscopic resection
* history of other malignancy except for appropriately treated superficial basal cell skin cancer
* Medical contraindications to anesthesia
* Patients with uncontrolled psychiatric disease or medical disease incompatible with the protocol
* Impossibility to respect the medical follow-up of the protocol for geographical, social or psychic reasons
50 Years
75 Years
MALE
No
Sponsors
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Centre Francois Baclesse
OTHER
Responsible Party
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Centre François Baclesse
Locations
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Centre François Baclesse
Caen, Basse-normandie, France
Countries
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Other Identifiers
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CURIEBOOST
Identifier Type: -
Identifier Source: org_study_id