NCT03809000

A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: RTOG Foundation, Inc. · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

Detailed description

PRIMARY OBJECTIVE: To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	daily fractions
DRUG	Enzalutamide	tablet
DRUG	Bicalutamide	tablet
DRUG	GnRH analog	Injection

Timeline

• Start date: 2019-04-15
• Primary completion: 2023-04-07
• Completion: 2029-09-15
• First posted: 2019-01-18
• Last updated: 2025-12-30
• Results posted: 2024-10-16

Locations

108 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study