Stereotactic Volumetric Radiotherapy in Prostate Cancer
NCT ID: NCT02423889
Last Updated: 2016-05-11
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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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2013-04-30
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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1
Stereotactic radiotherapy with a total dose of 36.25 Gy in 5 fractions (7.25 Gy per fraction, 2 fractions per week) in low risk prostate cancer patients is delivered to evaluate acute and subacute toxicty
Radiotherapy
Interventions
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Radiotherapy
Eligibility Criteria
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Inclusion Criteria
* Age≥ 18 years
* Life expectancy≥ 10 years
* Clinical negative nodes (N0)
* No metastasis presence (M0)
* No previous pelvic radiation therapy
* Total PSA≤10 ng/ml
* Gleason score ≤ 6
* T1-2
* ≤ 3 positive biopsy at prostatic mapping
* Signed informed consent
Exclusion Criteria
* Inflammatory bowel disease, collagen- vascular disorders or active autoimmune disorders
* Anticoagulant treatment in progress
* Hip or pelvic presence of medical devices that could prevent a correct image acquisition
* Symptomatic haemorrhoidal disease
* Adverse reactions to iodinate or paramagnetic contrast media
* Previous malignant cancer, except basocellular skin tumour or other tumours healed since 5 years
* Previous pelvic radiotherapy
* Psychiatric disorder that preclude to obtain informed consent
18 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
OTHER
Responsible Party
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Stefano Vagge
MD
Locations
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IRCCS AOU San Martino-IST
Genoa, GE, Italy
AO Città della salute e della scienza - Molinette
Turin, TO, Italy
Istituto del Radio "O. Alberti" Spedali Civili - University of Brescia
Brescia, , Italy
Countries
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Other Identifiers
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RITS13.001
Identifier Type: -
Identifier Source: org_study_id
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