drugset / Trial / NCT05628363

Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer

NCT05628363

NaSingle-groupOpen-labelTreatment

Summary

This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. The hypothesis is that this treatment approach will be safe and feasible with \<15% of patients experiencing an acute CTCAEv5 grade ≥3 genitourinary (GU) or gastrointestinal (GI) adverse event.

Timeline

Start
2023-01-18
Primary completion
2025-10-25
Completion
2030-07-25

Drugs

EvaluationDrugModalityDoseRoute
Background Bicalutamide Other / unclassified
Background Degarelix Other / unclassified
Background Goserelin Other / unclassified
Background Leuprolide Other / unclassified
Background Relugolix Small molecule
Background flutamide Small molecule

Indications