NCT00967863

Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	3-dimensional conformal radiation therapy	Patients undergo radiotherapy
RADIATION	intensity-modulated radiation therapy	Patients undergo radiotherapy

Timeline

• Start date: 2008-10-01
• Primary completion: 2015-03-01
• Completion: 2026-10-01
• First posted: 2009-08-28
• Last updated: 2024-12-18

Locations

25 sites across 1 country: France