A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 19, 2021

Primary Completion Date

October 19, 2025

Study Completion Date

October 19, 2025

Conditions
Prostate Cancer
Interventions
BIOLOGICAL

Androgen deprivation therapy (ADT)

ADT will include bicalutamide 50 mg PO daily started 1-2 weeks before leuprolide 22.5mg IM or SQ delivered every 3 months x 2. Bicalutamide will be continued through radiation and then discontinued on the day of the last fraction. Leuprolide can be given at different doses, but must be given for a total planned duration of 6 months.

RADIATION

Brachytherapy

After approximately 3 months (+/- 1 month) of neoadjuvant ADT, patients will undergo general anesthesia for outpatient transperineal high dose rate (HDR) interstitial prostate brachytherapy implant.

RADIATION

Hypofractionated pelvic External beam radiation

Patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER