Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer
NCT ID: NCT01704027
Last Updated: 2014-09-18
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
28 participants
INTERVENTIONAL
2012-10-31
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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Radiotherapy
Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation
Simultaneous integrated boost intensity-modulated arctherapy
Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions :
* Pelvis : 55,5 Gy (1,85 Gy/fr)
* Seminal vesicles : 66 Gy (2,2 Gy/fr)
* Prostate : 72 Gy (2,4 Gy/fr)
Androgen deprivation
Patients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy.
Interventions
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Simultaneous integrated boost intensity-modulated arctherapy
Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions :
* Pelvis : 55,5 Gy (1,85 Gy/fr)
* Seminal vesicles : 66 Gy (2,2 Gy/fr)
* Prostate : 72 Gy (2,4 Gy/fr)
Androgen deprivation
Patients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy.
Eligibility Criteria
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Inclusion Criteria
2. High risk localized adenocarcinoma defined by at least one of the following criteria:
* Clinical stage T2c, T3 or T4
* Gleason score ≥ 8
* Prostate-specific antigen (PSA)≥ 20 ng/ml and ≤ 100 ng/ml
3. Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
4. No pelvic adenopathy ≥ 15 mm on CT or MRI,
5. Absence of bone and/or visceral metastasis
6. Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation
7. Absence of prior pelvic radiotherapy,
8. Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy,
9. Age ≥ 18 years and ≤ 85 years
10. ECOG performance status ≤ 1,
11. Estimated life expectancy \> 5 years
12. Membership of a social security system,
13. Signed informed consent.
Exclusion Criteria
2. pN1 patients (lymph node dissection after histologically proven)
3. PSA \> 100 ng/ml
4. History of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin)
5. Patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm Hg systolic and / or ≥ 90 mm Hg diastolic)
6. Contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease of the digestive tract, etc ...)
7. Contra-indication to agonists or antagonists of LH-RH
8. Bilateral hip prosthesis,
9. Patients already included in another clinical trial with an experimental molecule,
10. Persons deprived of liberty or under guardianship
11. Unable to undergo medical test for geographical, social or psychological.
18 Years
85 Years
MALE
No
Sponsors
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Centre Georges Francois Leclerc
OTHER
Responsible Party
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Principal Investigators
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Etienne MARTIN, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Georges François Leclerc
Locations
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Centre Georges-François Leclerc
Dijon, Burgundy, France
Countries
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Other Identifiers
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2012-A00694-39
Identifier Type: -
Identifier Source: org_study_id
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