NCT05667636

Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP

Early Salvage Stereotactic Radiotherapy (esSBRT) for Biochemical Failure After Radical Prostatectomy :a Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients. The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.

Detailed description

The present study aims at delivering 30 Gy to the prostatic bed in 5 fractions. At the same time, the pelvic nodes will be covered to 25 Gy, but in those patients considered at low risk of nodal involvement. In patients with evidence of macroscopic disease at the tumor bed through DCE-MRI, 40 Gy will be delivered in 5 fractions. Selected patients will receive 6-month LHRH analogue preceded by Bicalutamide tablet 50 mg, daily, for 2 weeks to control for possible tumor flare.

Conditions

• Prostatic Neoplasm

Interventions

Type	Name	Description
RADIATION	salvage SBRT	steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer

Timeline

• Start date: 2022-09-27
• Primary completion: 2023-09-27
• Completion: 2024-09-27
• First posted: 2022-12-28
• Last updated: 2022-12-28

Locations

1 site across 1 country: Italy