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

PHASE2RecruitingINTERVENTIONAL
Enrollment

392

Participants

Timeline

Start Date

April 16, 2024

Primary Completion Date

April 16, 2030

Study Completion Date

April 16, 2031

Conditions
Prostate Cancer
Interventions
DRUG

Leuprolide, Degarelix or Relugolix

Patients assigned to the androgen deprivation therapy (ADT) arm will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.

RADIATION

Stereotactic body radiation therapy/radiosurgery (SBRT)

SBRT will be directed to the prostate and delivered with a prescription dose of 40 Gy in 5 fractions prescribed to the 95% isodose line encompassing the planning target volume. Intra-fraction motion targeting and target position corrections will be utilized for each of the 5 treatment fractions.

Trial Locations (1)

10016

RECRUITING

NYU Langone Health, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER