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

Prostate Cancer Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00967863
• Study type: Interventional
• Source: UNICANCER
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2008
• Completion date: October 2026