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

Prostate Cancer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06397703
Study type Interventional
Source NYU Langone Health
Contact Dayna Leis, RN
Phone 347-266-2630
Email Dayna.Leis@nyulangone.org
Status Recruiting
Phase Phase 3
Start date April 16, 2024
Completion date April 16, 2028
View Details
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