drugset / Trial / NCT06397703

ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

NCT06397703

Phase 2 Recruiting 392 enrolled NYU Langone Health
Non-randomizedParallel-groupOpen-labelTreatment

Summary

For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease. All patients will be followed every 6 months for up to 5 years from the first patient treated and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.

Timeline

Start
2024-04-16
Primary completion
2030-04-16
Completion
2031-04-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Degarelix Other / unclassified Other
Subject Leuprolide Other / unclassified Other
Subject Relugolix Small molecule Oral

Indications