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termination of the trial after interim analysis. the main criterion could not be reached
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The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Experimental | Patient will receive a pelvic and prostatic simultaneous integrated boost intensity-modulated arctherapy (SIB-IMAT) in combination with three years of androgen deprivation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simultaneous integrated boost intensity-modulated arctherapy | Radiation | Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions :
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Acute urinary and rectal toxicities as a Measure of treatment specific Safety and Tolerability | Acute urinary and rectal toxicities will be assessed according to the NCI CTCAE v4.0 quotation each week during radiotherapy treatment period up to six months after the end of the radiotherapy treatment period. | From start of radiotherapy to six months after the end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the late urinary and rectal toxicities | for each patient every 6 months after the end of radiotherapy up to 5 years. | |
| Evaluate the 5-year biochemical-free survival | for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years. |
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Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate
High risk localized adenocarcinoma defined by at least one of the following criteria:
Patient cN0, pN0 or Nx (negative lymphadenectomy or no lymphadenectomy)
No pelvic adenopathy ≥ 15 mm on CT or MRI,
Absence of bone and/or visceral metastasis
Androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation
Absence of prior pelvic radiotherapy,
Absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy,
Age ≥ 18 years and ≤ 85 years
ECOG performance status ≤ 1,
Estimated life expectancy > 5 years
Membership of a social security system,
Signed informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Etienne MARTIN, MD | Centre Georges François Leclerc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges-François Leclerc | Dijon | Burgundy | 21079 | France |
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| Androgen deprivation | Drug | 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. |
|
| Evaluate the metastase-free survival | for each patient from zero day up to 7 day after the end of radiotherapy, 6 weeks, 3 months, and every 6 months after the end of radiotherapy up to 5 years. |
| To evaluate the specific survival | for each patient from inclusion up to 5 years after the end of radiotherapy. |
| To evaluate the overall survival | for each patient from inclusion up to 5 years after the end of radiotherapy. |
| To evaluate the quality of life | inclusion day, from zero day up to 7 day after the end of radiotherapy, 6 weeks after the end of the radiotherapy, 3 months after the end of the radiotherapy, every 6 months after the end of radiotherapy up to 5 years. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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