ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer - Trial NCT06397703
Access comprehensive clinical trial information for NCT06397703 through Pure Global AI's free database. This Phase 3 trial is sponsored by NYU Langone Health and is currently Recruiting. The study focuses on Prostate Cancer. Target enrollment is 392 participants.
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Study Focus
Sponsor & Location
NYU Langone Health
Timeline & Enrollment
Phase 3
Apr 16, 2024
Apr 16, 2028
Primary Outcome
Disease-Free Survival
Summary
For this proposed Phase III study, unfavorable intermediate risk prostate cancer patients
 will be randomized to receive 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 randomized and will undergo a routine
 24-30 months post-SBRT prostate biopsy to assess for local tumor control.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06397703
Non-Device Trial