Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy
OBJECTIVES:
Primary
- Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical
progression-free survival at 5 years in patients with unfavorable-risk prostate cancer
receiving prolonged hormone therapy.
Secondary
- Evaluate overall and specific survival.
- Assess acute and late toxicities of different modalities (conformal or
intensity-modulated radiotherapy).
- Evaluate toxicities of the different doses with respect to hormonal therapy.
- Assess the quality of life (QLQ-C30 and PR 25).
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 80 Gy of conformal or intensity-modulated radiotherapy 5 times
a week for 7-8 weeks.
- Arm II: Patients undergo 70 Gy of conformal or intensity-modulated radiotherapy 5 times
a week for 7-8 weeks.
In both arms, patients receive goserelin subcutaneously once every 3 months for up to 3
years.
After completion of study treatment, patients are followed up periodically for 10 years.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Biochemical or clinical progression-free survival at 5 years
No
Christophe Hennequin, PhD
Principal Investigator
Hopital Saint-Louis
Unspecified
CDR0000649028
NCT00967863
October 2008
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