Drug intelligence / Profile preview

bicalutamide + leuprolide

Development stage
Phase 3
Lead developer
Memorial Sloan Kettering Cancer Center
Modality
Small Molecules, Peptides
Administration
Oral, Intramuscular, Subcutaneous
01

Overview

This specific androgen deprivation therapy (ADT) regimen is being evaluated by Memorial Sloan Kettering Cancer Center (MSKCC) in a Phase II clinical trial (NCT05100472) for patients with high-risk prostate cancer and low-intermediate Decipher genomic scores. The regimen consists of a 6-month course of combination therapy: bicalutamide, an oral small molecule androgen receptor antagonist, and leuprolide, a synthetic peptide GnRH receptor agonist. This pharmacological intervention is administered neoadjuvantly and concurrently with high-dose rate (HDR) brachytherapy and hypofractionated pelvic external beam radiation therapy. The goal of the ADT component is to achieve profound testosterone suppression and block androgen receptor signaling, thereby enhancing the efficacy of radiation and reducing the risk of cancer recurrence while minimizing the side effects associated with longer-term hormone suppression.

Other names
Short course ADTShort Course ADT + Radiation + Brachytherapy in High-Risk Prostate Cancer
02

Targets

AR (Adrenergic receptors)GnRHR (Gonadotropin-releasing hormone receptor)

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