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DRUG:

bicalutamide

i
Other names: ICI 176334, ICI176,334-1, ICI176334, ICI-176334
Company:
Generic mfg.
Drug class:
Androgen receptor inhibitor
10d
A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma (clinicaltrials.gov)
P1, N=30, Not yet recruiting, University of Nebraska | Initiation date: Oct 2024 --> Jan 2025
Trial initiation date
|
bicalutamide
10d
EORTC-1206: Androgen Deprivation Therapy in Advanced Salivary Gland Cancer (clinicaltrials.gov)
P2, N=149, Completed, European Organisation for Research and Treatment of Cancer - EORTC | Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Feb 2024
Trial completion • Trial completion date • Metastases
|
AR expression
|
cisplatin • carboplatin • paclitaxel • doxorubicin hydrochloride • bicalutamide • triptorelin
13d
Targeted Therapy in Salivary Gland Cancer: Prevalence of a Selected Panel of Actionable Molecular Alterations in a German Tertiary Referral Center Patient Cohort. (PubMed, Mol Diagn Ther)
Our data indicate that targeted therapy using e.g., trastuzumab deruxtecan, bicalutamide, pembrolizumab, cetuximab, entrectinib or sacituzumab govitecan might be a promising option especially for a relevant subset of patients with RM-SGC not suitable for salvage surgery. However, evidence from clinical studies regarding response rates to these therapies remains sparse, which underlines the need of multicenter clinical trials.
Journal • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • AR (Androgen receptor) • NTRK (Neurotrophic receptor tyrosine kinase) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
HER-2 overexpression • HER-2 amplification • HER-2 expression • EGFR overexpression • TROP2 overexpression • HER-2 elevation • NTRK1 translocation
|
Keytruda (pembrolizumab) • Erbitux (cetuximab) • Rozlytrek (entrectinib) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy) • bicalutamide
16d
INTREPId (INTermediate Risk Erection PreservatIon Trial) (clinicaltrials.gov)
P2, N=234, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting
Enrollment closed
|
Nubeqa (darolutamide) • bicalutamide
18d
CA209-8H3: Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients (clinicaltrials.gov)
P2, N=30, Active, not recruiting, Providence Health & Services | Trial completion date: Apr 2026 --> Jan 2026 | Trial primary completion date: Aug 2024 --> Jan 2025
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
HER-2 negative • AR positive
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • bicalutamide
25d
New P3 trial • Metastases
|
abiraterone acetate • bicalutamide • Orgovyx (relugolix) • leuprolide acetate for depot suspension • Yonsa (abiraterone acetate)
1m
Ribociclib and Bicalutamide in AR+ TNBC (clinicaltrials.gov)
P1/2, N=37, Recruiting, Kari Wisinski | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
|
HER-2 negative • AR positive • HER-2 negative + ER positive
|
Kisqali (ribociclib) • bicalutamide
1m
Systemic treatments in recurrent or metastatic salivary gland cancer: a systematic review. (PubMed, ESMO Open)
Systemic treatments contribute to the survival of patients with salivary gland cancer at relapsed or newly advanced stages. The response to treatment is heavily influenced by histological subtype and treatment specificity.
Review • Journal • Metastases
|
AR (Androgen receptor)
|
HER-2 overexpression • AR overexpression • AR expression • KIT expression
|
Herceptin (trastuzumab) • bicalutamide
2ms
A randomized phase II trial on the addition of dutasteride to combined androgen blockade therapy versus combined androgen blockade therapy alone in patients with advanced or metastatic salivary duct carcinoma - the DUCT study protocol. (PubMed, BMC Cancer)
The DUCT study addresses an unmet medical need by investigating the repurposing of dutasteride to enhance treatment response and improve clinical outcome for patients with R/M SDC, especially those with limited alternative treatment options, such as HER2-negative cases. By repurposing a registered low-cost drug, this trial's findings could be readily applied into clinical practice.
Clinical • Clinical protocol • P2 data • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • SRD5A1 (Steroid 5 Alpha-Reductase 1)
|
HER-2 negative • AR positive
|
bicalutamide • goserelin acetate
2ms
A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan (clinicaltrials.gov)
P=N/A, N=979, Completed, Janssen Pharmaceutical K.K. | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Aug 2024
Trial completion • Trial completion date • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • goserelin acetate
2ms
Phase classification
|
bicalutamide • triptorelin
2ms
TET3 is expressed in prostate cancer tumor-associated macrophages and is associated with anti-androgen resistance. (PubMed, Clin Transl Oncol)
The efficacy of ADT in prostate cancer is related to the expression of TET3 in TAMs, and TET3 may be a potential therapeutic target for coordinating ADT.
Journal
|
TET3 (Tet Methylcytosine Dioxygenase 3)
|
Tafinlar (dabrafenib) • paclitaxel • docetaxel • cyclophosphamide • vincristine • bicalutamide
3ms
Bicalutamide reveals immunomodulatory effects in prostate cancer by regulating immunogenic dendritic cell maturation. (PubMed, Tissue Cell)
These findings suggest that beyond its established anti-androgen role, Bicalutamide may exert anti-tumor effects through the modulation of DCs-mediated immune responses. This novel immunomodulatory feature holds promise for the development of novel therapies, including combination therapies, in prostate cancer treatment.
Journal • Immunomodulating
|
IL10 (Interleukin 10) • CSF2 (Colony stimulating factor 2) • TGFB1 (Transforming Growth Factor Beta 1) • IL4 (Interleukin 4) • ANXA5 (Annexin A5) • CD86 (CD86 Molecule)
|
bicalutamide
3ms
Simultaneous Robotic Sphincter-Preserving Rectal Resection and Prostatectomy for Rectal Gastrointestinal Stromal Tumor and Prostatic Cancer. (PubMed, Ann Surg Oncol)
Simultaneous robotic sphincter-preserving local rectal resection and prostatectomy can be feasibly and safely performed following neoadjuvant therapy in cases of synchronous rectal GIST and prostate cancer.
Journal • Stroma
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
imatinib • bicalutamide
3ms
ASB1 inhibits prostate cancer progression by destabilizing CHCHD3 via K48-linked ubiquitination. (PubMed, Am J Cancer Res)
Notably, the group with low ASB1 expression exhibited an increased proportion of M2 macrophages and showed resistance to immune checkpoint inhibitors and cisplatin, but remained sensitive to androgen-receptor-targeting drug bicalutamide. Cell rescue experiments further demonstrated that ASB1 inhibits prostate cancer cell through the CHCHD3/reactive oxygen species (ROS) pathway. Taken together, our study indicated that ASB1 functions as a tumor suppressor by inhibiting CHCHD3/ROS signaling, thereby playing a vital part in prevention of prostate cancer proliferation, clonogenicity, and migration.
Journal • IO biomarker
|
AR (Androgen receptor)
|
cisplatin • bicalutamide
3ms
PRESTO: A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer (clinicaltrials.gov)
P3, N=504, Active, not recruiting, Alliance Foundation Trials, LLC. | Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date
|
abiraterone acetate • prednisone • bicalutamide • Erleada (apalutamide) • Firmagon (degarelix) • leuprolide acetate for depot suspension
4ms
New P2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • Orgovyx (relugolix) • leuprolide acetate for depot suspension
4ms
Epitranscriptomic mechanisms of androgen signalling and prostate cancer. (PubMed, Neoplasia)
ADTs act by either blocking androgen biosynthesis (e.g. abiraterone) or blocking AR function (e.g. bicalutamide, enzalutamide, apalutamide, darolutamide). Given the need for novel approaches to treat PCa, there is significant interest in new therapies that target m6A that modulate AR expression and androgen signalling. This review critically summarises the potential benefit of such epitranscriptomic therapies for PCa patients.
Review • Journal
|
AR (Androgen receptor) • FTO (Alpha-Ketoglutarate-Dependent Dioxygenase FTO) • ALKBH5 (AlkB Homolog 5, RNA Demethylase) • METTL3 (Methyltransferase Like 3)
|
Xtandi (enzalutamide capsule) • abiraterone acetate • Nubeqa (darolutamide) • bicalutamide • Erleada (apalutamide)
4ms
A novel mitochondrial function-associated programmed cell death-related prognostic signature for predicting the prognosis of early breast cancer. (PubMed, Front Genet)
Four mitochondrial function-associated PCD-related genes were identified, including CREB3L1, CAPG, SPINT1, and GRK3, and the prognostic risk model and nomogram were established for predicting the survival of early breast cancer patient. The chemotherapeutics, containing FH535, MK.2206, and bicalutamide, might be used for early breast cancer.
Journal • IO biomarker
|
LAG3 (Lymphocyte Activating 3) • CREB3L1 (CAMP Responsive Element Binding Protein 3 Like 1) • SPINT1 (Serine Peptidase Inhibitor, Kunitz Type 1)
|
MK-2206 • bicalutamide
4ms
New P1 trial
|
bicalutamide
4ms
Enrollment change • Trial completion date • Surgery
|
docetaxel • Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • flutamide • nilutamide • Firmagon (degarelix) • Viadur (leuprorelin implant)
4ms
Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) (clinicaltrials.gov)
P1/2, N=46, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
Ibrance (palbociclib) • bicalutamide
5ms
BicaBCa: A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer (clinicaltrials.gov)
P2, N=160, Recruiting, CHU de Quebec-Universite Laval | Trial primary completion date: Jul 2024 --> Jul 2025
Trial primary completion date
|
bicalutamide
5ms
CA209-8H3: Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients (clinicaltrials.gov)
P2, N=30, Active, not recruiting, Providence Health & Services | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Aug 2024
Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • bicalutamide
5ms
In silico studies on the molecular interactions of steroid hormones and steroid hormone mimicking drugs in the androgen receptor binding cleft - Implications for prostate cancer treatment. (PubMed, Steroids)
We used in silico molecular modelling to explore interactions between ARs, androgens (testosterone, dihydrotestosterone (DHT)) and drugs used to treat (bicalutamide) and manage (dexamethasone, prednisone, hydrocortisone) PCa. However, hydrocortisone and bicalutamide form Arg752 and Asn705 H-bonds indicating agonism. Our results suggest that as PCa progresses the resulting mutations will change the proliferative response to androgens and their drug mimics, which have implications for the treatment of prostate cancer.
Journal
|
AR (Androgen receptor)
|
bicalutamide
5ms
Exploring and clinical validation of prognostic significance and therapeutic implications of copper homeostasis-related gene dysregulation in acute myeloid leukemia. (PubMed, Ann Hematol)
Drug sensitivity analysis suggested potential therapeutic agents targeting copper homeostasis, including Bicalutamide and Sorafenib. In conclusion, we shed light on the expression patterns and biological functions of CHRGs in AML. The developed risk models provided prognostic implications for patient survival, offering valuable information on the regulatory characteristics of CHRGs and potential avenues for personalized treatment in AML.
Journal
|
MAPK1 (Mitogen-activated protein kinase 1) • ATP7A (ATPase Copper Transporting Alpha) • LIPT1 (Lipoyltransferase 1) • PDHA1 (Pyruvate Dehydrogenase E1 Subunit Alpha 1) • SLC31A1 (Solute Carrier Family 31 Member 1)
|
sorafenib • bicalutamide
6ms
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS (clinicaltrials.gov)
P3, N=1503, Active, not recruiting, Aragon Pharmaceuticals, Inc. | Trial primary completion date: Jun 2024 --> Jun 2026
Trial primary completion date • Metastases
|
bicalutamide • Erleada (apalutamide)
6ms
Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer (clinicaltrials.gov)
P=N/A, N=74, Active, not recruiting, University of Chicago | Trial completion date: Feb 2024 --> Feb 2026
Trial completion date
|
bicalutamide • finasteride
6ms
A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan (clinicaltrials.gov)
P=N/A, N=979, Active, not recruiting, Janssen Pharmaceutical K.K. | Trial primary completion date: Oct 2025 --> Aug 2024
Trial primary completion date
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • goserelin acetate
6ms
Prognostic outcomes in Japanese patients with metastatic castration-sensitive prostate cancer: Comparative assessments between conventional androgen deprivation therapy (ADT) and ADT with novel androgen receptor signal inhibitor. (PubMed, Int J Urol)
Combined use of ARSIs with ADT could improve the prognostic outcomes of mCSPC patients, particularly those in the LATITUDE high-risk group, in real-world clinical practice in Japan.
Clinical • Journal • Metastases
|
CRP (C-reactive protein)
|
Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide)
6ms
Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone and Apalutamide for Rising PSA After RP (FORMULA-509) (clinicaltrials.gov)
P2, N=345, Active, not recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Oct 2022 --> Apr 2025
Trial primary completion date
|
abiraterone acetate • prednisone • bicalutamide • Erleada (apalutamide)
7ms
DUCT: Phase II Dutasteride in Combination With CAB vs CAB in SDC (clinicaltrials.gov)
P2, N=26, Recruiting, Radboud University Medical Center | N=98 --> 26
Enrollment change • Combination therapy • Metastases
|
AR (Androgen receptor)
|
AR positive
|
bicalutamide • goserelin acetate
7ms
Micro RNAs to Predict Response to Androgen Deprivation Therapy (clinicaltrials.gov)
P=N/A, N=42, Active, not recruiting, Medical College of Wisconsin | N=60 --> 42
Enrollment change
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • triptorelin • goserelin acetate • leuprolide acetate for depot suspension
7ms
Trial completion date
|
MK-2206 • bicalutamide
8ms
In vitro combination effects of plant-derived quercetin with synthetic bicalutamide on prostate cancer and normal cell lines: in silico comparison. (PubMed, In Silico Pharmacol)
The intake of foods high in polyphenolic compounds can help to prevent prostate cancer. Examination of quercetin on several cell lines will provide a definite conclusion to combat cancers.
Preclinical • Journal
|
AR (Androgen receptor)
|
bicalutamide
8ms
Immunoprofiles and Oncologic Outcomes of 15 Patients with Androgen Receptor-Positive Salivary Duct Carcinoma. (PubMed, Cancers (Basel))
Despite only including AR+ SDC of the parotid, immunoprofiles, such as expression of HER-2, were highly variable, highlighting the potential to tailor systemic regimens based on individual histologic profiles in the future. Studies with larger patient numbers using tumor-specific molecular profiling and tumor heterogeneity analyses are justified to better understand the biology of these tumors. Molecularly informed treatment approaches, including the potential use of AR- and HER-2/Neu-directed therapies upfront in the definitive setting, may hold future promise to further improve outcomes for these patients.
Journal
|
AR (Androgen receptor)
|
HER-2 expression • AR positive
|
Herceptin (trastuzumab) • bicalutamide • leuprolide acetate for depot suspension
8ms
Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer (clinicaltrials.gov)
P1, N=20, Completed, Sidney Kimmel Cancer Center at Thomas Jefferson University | Active, not recruiting --> Completed
Trial completion • Metastases
|
bicalutamide • cabazitaxel
8ms
A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan (clinicaltrials.gov)
P=N/A, N=979, Active, not recruiting, Janssen Pharmaceutical K.K. | Trial completion date: Aug 2024 --> Oct 2025 | Trial primary completion date: Aug 2024 --> Oct 2025
Trial completion date • Trial primary completion date • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • goserelin acetate
8ms
Ribociclib and Bicalutamide in AR+ TNBC (clinicaltrials.gov)
P1/2, N=37, Recruiting, Kari Wisinski | Trial primary completion date: Jan 2024 --> May 2024
Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
|
HER-2 negative • AR positive
|
Kisqali (ribociclib) • bicalutamide
8ms
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
P2, N=30, Recruiting, Peking Union Medical College | Initiation date: Dec 2023 --> May 2024
Trial initiation date • Metastases
|
cisplatin • erlotinib • carboplatin • sorafenib • AiTan (rivoceranib) • albumin-bound paclitaxel • abiraterone acetate • bicalutamide • larotinib (Z650) • ESG401 • Entyvio (vedolizumab)
8ms
MiR-15b-3p weakens bicalutamide sensitivity in prostate cancer via targeting KLF2 to suppress ferroptosis. (PubMed, J Cancer)
In conclusion, miR-15b-3p has strong potential as a screening and diagnostic biomarker with reliable prospects for clinical application. Furthermore, because patients with high miR-15b-3p and low KLF2 expression have a greater risk of BIC resistance and malignant progression, targeting the miRNA and its downstream protein may be a new treatment strategy.
Journal
|
GPX4 (Glutathione Peroxidase 4) • SLC7A11 (Solute Carrier Family 7 Member 11) • MIR15B (MicroRNA 15b)
|
bicalutamide
8ms
Effect of Casodex on Tumour Hypoxia - Prostate Cancer (clinicaltrials.gov)
P=N/A, N=30, Completed, University Health Network, Toronto | Active, not recruiting --> Completed
Trial completion
|
bicalutamide