Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05100472
PHASE2

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether combining a shorter than standard course of ADT with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.

Official title: Phase II Trial of Short Course Androgen Deprivation, Hypofractionated Pelvic Radiation and a Brachytherapy Boost for NCCN High-Risk Prostate Cancer With Low-Intermediate Risk Decipher Genomic Score

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2021-10-19

Completion Date

2026-10-19

Last Updated

2025-11-04

Healthy Volunteers

No

Conditions

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.

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States