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

Phase 2 Active not recruiting 188 enrolled RTOG Foundation, Inc. Astellas Pharma Inc · collab Pfizer · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2019-04-15
Primary completion: 2023-04-07
Completion: 2029-09-15

Outcome

Missed primary endpoint

registry analysis (superiority test); SRT + Standard ADT vs SRT + Enhanced ADT; p = 0.0671 NCT03809000 ↗

Publications

Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	160 mg	—
Comparator	Bicalutamide	Other / unclassified	50 mg	—
Background	Decapeptyl	Unknown	—	Other
Background	Goserelin	Other / unclassified	—	Other
Background	Leuprolide	Other / unclassified	—	Other