drugset / Trial / NCT07313241

Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)

NCT07313241

Phase 2 Recruiting 68 enrolled University of Texas Southwestern Medical Center
NaSingle-groupOpen-labelTreatment

Summary

This Phase II, single arm study evaluates a PSA-response-adapted approach to salvage radiotherapy after radical prostatectomy for prostate cancer. All participants will receive hypo-fractionated stereotactic radiotherapy to the prostate fossa. At 5 weeks, biochemical response will be assessed. responders will proceed to observation, while non responders will receive sequential pelvic nodal radiotherapy and 4 months of androgen deprivation therapy (ADT). The study aims to determine whether this response base approach achieves non inferior 2 year freedom from progression compared with historical outcomes using routine pelvic nodal radiotherapy and ADT in all patients.

Timeline

Start
2025-11-14
Primary completion
2030-11-14
Completion
2030-11-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Degarelix Other / unclassified
Subject Goserelin Other / unclassified
Subject Leuprolide Other / unclassified

Indications