bicalutamide

P2, N=23, Recruiting, Martin T. King, MD, PhD | Not yet recruiting --> Recruiting

P2, N=20, Not yet recruiting, Washington University School of Medicine

P2, N=29, Active, not recruiting, City of Hope Medical Center | Trial completion date: Mar 2026 --> Feb 2027

Increasing interest in AR biology has led to the evaluation of several anti-androgen therapies in AR-positive TNBC, including agents such as enzalutamide, enobosarm, orteronel, bicalutamide, and seviteronel. Although clinical activity has generally been modest, these studies highlight the potential relevance of AR-targeted strategies in selected patient subgroups. This review summarizes current knowledge on androgen and AR signaling in TNBC, integrating molecular mechanisms, preclinical evidence, and clinical studies, and discusses emerging therapeutic strategies aimed at improving patient treatment outcomes.

This study not only provides mechanistic insights into the role of DUOXA1 in bicalutamide resistance but also highlights the HIF1α-DNMT1-DUOXA1 axis as a critical regulator of resistance. Our work suggests potential therapeutic strategies to overcome resistance through epigenetic modulation and activation of DUOXA1, offering a novel perspective on the molecular mechanisms of bicalutamide resistance and paving the way for the development of improved treatment approaches for advanced prostate cancer.

P1, N=80, Recruiting, University of Wisconsin, Madison | Not yet recruiting --> Recruiting

P2, N=108, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027

We report an 85-year-old male with a history of Gleason 4+3 acinar adenocarcinoma, managed conservatively with long-term bicalutamide monotherapy because of his clinical stability...Literature review highlights venous or lymphatic spread as probable pathways, with prognosis varying widely. This case underscores the importance of considering secondary malignancy in penile lesions, utilizing histopathology and immunohistochemistry for definitive diagnosis, and tailoring management to patient comorbidities and preferences to preserve quality of life.

P=N/A, N=800, Not yet recruiting, Bayer

P1/2, N=42, Recruiting, Icahn School of Medicine at Mount Sinai | Trial completion date: Dec 2027 --> Jun 2028 | Trial primary completion date: Dec 2026 --> Jun 2027

The CALLY index is an accessible and independent prognostic biomarker for OS and CRPC progression in mHSPC. Its integration into clinical assessment could enhance risk stratification and support personalized treatment planning, potentially improving long-term patient outcomes.