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NCT06397703Recruiting

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

A Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy And Ultra-Hypofractionated SBRT Versus Ultra-Hypofractionated SBRT Alone For Unfavorable Intermediate Risk Prostate Cancer
NYU Langone HealthPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Prostate Cancer
Drug/Device/Intervention
Leuprolide, Degarelix or Relugolix
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
NYU Langone Health
Location
New York, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Apr 16, 2024
End date
Apr 16, 2028
Enrollment
392 participants
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
Malignant neoplasm of prostateHyperplasia of prostateDisorder of prostate, unspecifiedOther disorders of prostateCarcinoma in situ: Prostate
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06397703
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.