NCT01704027

Safety Study of Pelvic and Prostatic SIB-IMRT With Long-term Androgen Deprivation for High Risk Localized Prostate Cancer

Prospective Phase II Study Evaluating the Feasibility of a Conformational Pelvic and Prostatic Radiotherapy With Simultaneous Integrated Boost Modulated-intensity Arctherapy (SIB-IMAT) in Combination With Long Term Androgen Deprivation for High Risk Localized Prostate Cancer.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Centre Georges Francois Leclerc · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	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)
DRUG	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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-03-01
• First posted: 2012-10-11
• Last updated: 2014-09-18

Locations

1 site across 1 country: France