docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • triptorelin • goserelin acetate • leuprolide acetate for depot suspension

23d

Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer (clinicaltrials.gov)

P2, N=108, Active, not recruiting, National Cancer Institute (NCI)

23 days ago

Trial completion date

MK-2206 • bicalutamide

27d

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.

27 days ago

Preclinical • Journal

AR (Androgen receptor)

bicalutamide

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.

1 month ago

Journal

AR (Androgen receptor)

HER-2 expression • AR positive

Herceptin (trastuzumab) • bicalutamide • leuprolide acetate for depot suspension

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

1 month ago

Trial completion • Metastases

bicalutamide • cabazitaxel

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

1 month ago

Trial completion date • Trial primary completion date • Metastases

docetaxel • Xtandi (enzalutamide capsule) • abiraterone acetate • bicalutamide • Erleada (apalutamide) • goserelin acetate

Ribociclib and Bicalutamide in AR+ TNBC (clinicaltrials.gov)

P1/2, N=37, Recruiting, Kari Wisinski | Trial primary completion date: Jan 2024 --> May 2024

1 month ago

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

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

1 month ago

Trial initiation date • Metastases

cisplatin • erlotinib • carboplatin • sorafenib • AiTan (rivoceranib) • albumin-bound paclitaxel • abiraterone acetate • bicalutamide • larotinib (Z650) • ESG401 • Entyvio (vedolizumab)

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.

1 month ago

Journal

GPX4 (Glutathione Peroxidase 4) • SLC7A11 (Solute Carrier Family 7 Member 11) • MIR15B (MicroRNA 15b)

bicalutamide

Effect of Casodex on Tumour Hypoxia - Prostate Cancer (clinicaltrials.gov)

P=N/A, N=30, Completed, University Health Network, Toronto | Active, not recruiting --> Completed

1 month ago

Trial completion

bicalutamide

Integrated Bioinformatics Analysis Identified ASNS and DDIT3 as the Therapeutic Target in Castrate-Resistant Prostate Cancer. (PubMed, Int J Mol Sci)

Bicalutamide-resistant prostate cancer cells derived from LNCaP were generated and named Bical R. RNA sequencing was used to identify differentially expressed genes (DEGs) between LNCaP and Bical R. In total, 631 DEGs (302 upregulated genes and 329 downregulated genes) were identified...Our study revealed a potential association between ASNS and DDIT3 and the progression to CRPC. These results may contribute to the development of potential therapeutic targets and mechanisms underlying CRPC progression, aiming to improve clinical efficacy in CRPC treatment.

1 month ago

Journal

ATF4 (Activating Transcription Factor 4) • DDIT3 (DNA-damage-inducible transcript 3) • ATF3 (Activating Transcription Factor 3) • EFNA5 (Ephrin A5)

bicalutamide

2ms

GL-V9 inhibits the activation of AR-AKT-HK2 signaling networks and induces prostate cancer cell apoptosis through mitochondria-mediated mechanism. (PubMed, iScience)

This disruption greatly increased the anti-PCa efficacy of the AR antagonist bicalutamide. In conclusion, we present a novel anti-PCa candidate and combination drug strategies to combat CRPC by intervening in the AR-AKT-HKII signaling network.

2 months ago

Journal

AR (Androgen receptor)

AR expression • AR negative

bicalutamide

2ms

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial (clinicaltrials.gov)

P1, N=2, Terminated, OHSU Knight Cancer Institute | Active, not recruiting --> Terminated; Low accrual

2 months ago

Trial termination

Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Venclexta (venetoclax) • Lynparza (olaparib) • Mekinist (trametinib) • erlotinib • Gilotrif (afatinib) • Yervoy (ipilimumab) • Ibrance (palbociclib) • dasatinib • Zelboraf (vemurafenib) • Tafinlar (dabrafenib) • carboplatin • Imfinzi (durvalumab) • sorafenib • Rozlytrek (entrectinib) • imatinib • Sutent (sunitinib) • everolimus • Nerlynx (neratinib) • Iclusig (ponatinib) • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • Lorbrena (lorlatinib) • Lenvima (lenvatinib) • bortezomib • doxorubicin hydrochloride • capecitabine • Verzenio (abemaciclib) • Xtandi (enzalutamide capsule) • Cabometyx (cabozantinib tablet) • albumin-bound paclitaxel • Stivarga (regorafenib) • abiraterone acetate • oxaliplatin • Aliqopa (copanlisib) • Vizimpro (dacomitinib) • Zydelig (idelalisib) • daunorubicin • Zolinza (vorinostat) • Idhifa (enasidenib) • Farydak (panobinostat) • Erivedge (vismodegib) • Nubeqa (darolutamide) • bicalutamide • leucovorin calcium • cabazitaxel • Vesanoid (tretinoin) • fluorouracil topical

2ms

Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer (clinicaltrials.gov)

P1/2, N=60, Recruiting, Icahn School of Medicine at Mount Sinai | Trial completion date: Sep 2024 --> Oct 2026 | Trial primary completion date: Sep 2024 --> Apr 2025

2 months ago

Trial completion date • Trial primary completion date • Combination therapy • Metastases

HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)

HER-2 negative

Verzenio (abemaciclib) • bicalutamide

2ms

Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer (clinicaltrials.gov)

P2, N=29, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024

2 months ago

Trial completion date • Metastases

Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • Viadur (leuprorelin implant)

2ms

CANUCK-01: A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer. (clinicaltrials.gov)

P2, N=0, Withdrawn, CHU de Quebec-Universite Laval | N=69 --> 0 | Trial completion date: Dec 2025 --> Feb 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2025 --> Jan 2024

2 months ago

Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Metastases

Bavencio (avelumab) • bicalutamide

3ms

Determination of enzalutamide long-term safety and efficacy for castration-resistant prostate cancer patients after combined anti-androgen blockade followed by alternative anti-androgen therapy: a multicenter prospective DELC study. (PubMed, Jpn J Clin Oncol)

In the DELC study, the safety of enzalutamide was comparable to that in previous reports. Serum levels of neuron-specific enolase and interleukin-6 were suggested as prognostic factors for castration-resistant prostate cancer with potential clinical utility.

3 months ago

Journal

IL6 (Interleukin 6)

Xtandi (enzalutamide capsule) • bicalutamide • flutamide

3ms

Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer (clinicaltrials.gov)

P1, N=20, Completed, Medical University of South Carolina | Active, not recruiting --> Completed

3 months ago

Trial completion

docetaxel • bicalutamide • goserelin acetate • leuprolide acetate for depot suspension

3ms

Therapeutic Potential of Bipolar Androgen Therapy for Castration-Resistant Prostate Cancer: In Vitro and In Vivo Studies. (PubMed, Biomedicines)

Bicalutamide inhibited PCa cell viability but not in the adapted cell lines...In vivo, high AR-expressing LNCaP cells proliferated under castrate conditions, while BAT-treated xenografts exhibited significant growth inhibition with low Ki-67 and mitotic indexes and a high cell death index. This study provides preliminary evidence that BAT is effective for the treatment of CRPC through rapid cycling between supraphysiologic and near-castrate serum testosterone levels, inducing an anti-tumor effect.

3 months ago

Preclinical • Journal

AR (Androgen receptor)

AR overexpression • AR expression • AR splice variant 7 • AR-V7 expression • AR splice variant 7 expression

bicalutamide

3ms

Bicalutamide Therapy in Young Women With NAFLD and PCOS (clinicaltrials.gov)

P1, N=50, Recruiting, University of California, San Francisco | Not yet recruiting --> Recruiting

3 months ago

Enrollment open

bicalutamide

3ms

Unveiling a pH-Responsive Dual-Androgen-Blocking Magnetic Molecularly Imprinted Polymer for Enhanced Synergistic Therapy of Prostate Cancer. (PubMed, ACS Appl Mater Interfaces)

The nanodrug could selectively sequester testosterone from the prostate tumor through specific molecular imprinting sites and simultaneously deliver the AR inhibitory drug bicalutamide, which ultimately leads to enhanced synergistic therapy of prostate cancer...Additionally, the nanodrug also displayed excellent antitumor properties in a xenograft mouse model of prostate cancer without any sign of detrimental effects on healthy tissues and organs. Both in vitro and in vivo studies verified the augmented and synergistic therapeutic effects of FASC MIPs, and the proposed dual-androgen-blocking strategy could explore novel avenues in prostate cancer treatment.

3 months ago

Journal

AR (Androgen receptor)

bicalutamide

4ms

SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer (clinicaltrials.gov)

P2, N=1460, Active, not recruiting, UNICANCER | Trial completion date: Dec 2023 --> Dec 2024

4 months ago

Trial completion date • IO biomarker • Metastases

Avastin (bevacizumab) • Lynparza (olaparib) • cisplatin • carboplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel • 5-fluorouracil • Koselugo (selumetinib) • capecitabine • cyclophosphamide • Halaven (eribulin mesylate) • Truqap (capivasertib) • fexagratinib (ABSK091) • epirubicin • Caprelsa (vandetanib) • vincristine • vinorelbine tartrate • bicalutamide • mitomycin • vistusertib (AZD2014) • vinblastine • sapitinib (AZD8931)

4ms

Structure based docking and biological evaluation towards exploring potential anti-cancerous and apoptotic activity of 6-Gingerol against human prostate carcinoma cells. (PubMed, BMC Complement Med Ther)

Thus, this study validates 6-G as a potential drug candidate against human PCa. However, further study of the anticancer potency of 6-G has to be done before its use for PCa treatment.

4 months ago

Journal

ER (Estrogen receptor) • AR (Androgen receptor)

bicalutamide

4ms

The neutrophil extracellular traps-related gene signature predicts the prognosis of glioblastoma multiforme. (PubMed, Folia Neuropathol)

Patients in the high-risk group were more sensitive to bicalutamide, gefitinib, and dasatinib; patients in the low-risk group were associated with poor response to immunotherapy. The validation of the six genes in the prognostic model was consistent with the results of bioinformatics analysis. The NETs-based prognostic model and nomogram proposed in this study are promising prognostic prediction tools for GBM, which may provide new ideas for the development of precise tumour targeted therapy.

4 months ago

Journal • Gene Signature • IO biomarker

MAPK1 (Mitogen-activated protein kinase 1) • MMP9 (Matrix metallopeptidase 9) • G0S2 (G0/G1 Switch 2)

dasatinib • gefitinib • bicalutamide

4ms

Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer (clinicaltrials.gov)

P2, N=70, Recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Aug 2027 | Trial primary completion date: Dec 2023 --> Aug 2027

4 months ago

Trial completion date • Trial primary completion date

Talzenna (talazoparib) • abiraterone acetate • Eligard (leuprolide acetate) • bicalutamide • goserelin acetate • Firmagon (degarelix) • Viadur (leuprorelin implant) • Yonsa (abiraterone acetate)

4ms

S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer (clinicaltrials.gov)

P3, N=1313, Active, not recruiting, SWOG Cancer Research Network

4 months ago

Trial completion date • Metastases

bicalutamide • orteronel (TAK 700)

4ms

High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov)

P=N/A, N=163, Active, not recruiting, Stanford University

4 months ago

Trial completion date

bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension

4ms

Bicalutamide Therapy in Young Women With NAFLD and PCOS (clinicaltrials.gov)

P1, N=50, Not yet recruiting, University of California, San Francisco

4 months ago

Trial completion date • Trial initiation date • Trial primary completion date

bicalutamide

4ms

Differential gene regulation by a synthetic vitamin D receptor ligand and active vitamin D in human cells. (PubMed, PLoS One)

In an ATAC-seq assay, the effects of 1α,25(OH)2 D3 and DLAM-2b on chromatin reorganization were undetectable in HaCaT cells, while the effect of an androgen receptor (AR) antagonist (bicalutamide) was confirmed in prostate cancer cells (LNCaP) expressing endogenous AR...The upregulated and downregulated genes only partially overlapped between cells treated with 1α,25(OH)2D3 and those treated with DLAM-2b. Thus, the present findings illustrate a novel VDR ligand with gene regulatory activity differing from that of 1α,25(OH)2D3.

4 months ago

Journal

AR (Androgen receptor) • VDR (Vitamin D Receptor)

bicalutamide

5ms

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 completion date: Oct 2026 --> Dec 2028

5 months ago

Trial completion date • Metastases

bicalutamide • Erleada (apalutamide)

5ms

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular-based Stagingcarcinoma (clinicaltrials.gov)

P2, N=30, Recruiting, Peking Union Medical College

5 months ago

New P2 trial

cisplatin • erlotinib • carboplatin • sorafenib • AiTan (rivoceranib) • albumin-bound paclitaxel • bicalutamide • larotinib (Z650) • Entyvio (vedolizumab) • SHR-A1921

5ms

High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov)

P=N/A, N=163, Active, not recruiting, Stanford University | Phase classification: P1/2 --> P=N/A

5 months ago

Phase classification

bicalutamide • triptorelin • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension

5ms

ARCH: Contributions to Hypertension With Androgen Deprivation Therapy (clinicaltrials.gov)

P4, N=228, Recruiting, University of Colorado, Denver | Not yet recruiting --> Recruiting

5 months ago

Enrollment open

LCN2 (Lipocalin-2)

Xtandi (enzalutamide capsule) • bicalutamide • goserelin acetate • flutamide • leuprolide acetate for depot suspension

6ms

RADICALS-HD: RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery (clinicaltrials.gov)

P3, N=4236, Completed, University College, London | Unknown status --> Completed

6 months ago

Trial completion • Surgery

bicalutamide • goserelin acetate • leuprolide acetate for depot suspension

6ms

A Multicenter, Phase Ib/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer (SABCS 2023)

Phase I and II trials of bicalutamide in HR-negative and enzalutamide in both triple negative breast cancer (TNBC) and hormone receptor (HR) positive populations have shown safety and favorable clinical benefit rates (CBR)...We performed a retrospective, institutional study evaluating metastatic HR+ tumor samples with immunohistochemistry (IHC) from patients treated with CDK4/6 inhibitor, palbociclib...We define inactivity as DCR of 0.20 and activity as DCR of 0.35. To date, the study has recruited 21 participants, the goal accrual is 60 patients.

6 months ago

Clinical • P1/2 data • Combination therapy • Metastases

HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor) • RB1 (RB Transcriptional Corepressor 1) • CCND1 (Cyclin D1)

HR positive • HER-2 negative • AR positive • AR expression

Ibrance (palbociclib) • Verzenio (abemaciclib) • Xtandi (enzalutamide capsule) • bicalutamide

6ms

A phase II study of nivolumab plus ipilimumab and androgen receptor antagonist bicalutamide to stimulate thymic T cell generation in HER2-negative metastatic breast cancer (SABCS 2023)

The regimen of ipilimumab, nivolumab, plus bicalutamide is safe and clinically active in 1st/2nd-line HER2-negative MBC. Neither cohort crossed the Simon futility barrier for cohort expansion, however durable responses were observed including in PD-L1-negative patients, highlighting the unmet need for biomarkers to identify candidates for chemotherapy-sparing checkpoint blockade. Further research is indicated to evaluate the impact of AR antagonists on T-cell function and thymic stimulation in MBC.

6 months ago

P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases

HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)

HER-2 negative • PD-L1 negative • HR negative

Opdivo (nivolumab) • Yervoy (ipilimumab) • bicalutamide

6ms

Androgen Receptor Isoform V7 (AR-V7): A Promising Biomarker for Prognosticating Breast Cancer Aggressiveness (SABCS 2023)

This confers ligand-independent transcriptional activity to AR-V7 and makes it susceptible to nonsteroidal antiandrogens such as Bicalutamide or Enzalutamide which target the LBD of AR. It can serve as a screening marker of poor clinical outcomes and aid in appropriate therapeutic intervention. These outcomes, however, seek extensive prospective validation.

6 months ago

BRCA Biomarker

HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • AR (Androgen receptor)

AR expression • AR splice variant 7 • AR-V7 expression • AR splice variant 7 expression

Xtandi (enzalutamide capsule) • bicalutamide

7ms

Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer (clinicaltrials.gov)

P1, N=20, Active, not recruiting, Medical University of South Carolina | Trial completion date: Sep 2023 --> Dec 2023

7 months ago

Trial completion date • Metastases

docetaxel • bicalutamide • goserelin acetate • leuprolide acetate for depot suspension

7ms

The efficacy of natural bioactive compounds against prostate cancer: Molecular targets and synergistic activities. (PubMed, Phytother Res)

In addition, multiple studies have demonstrated that the isolated natural compounds: d-limonene, paeonol, lanreotide, artesunate, and bicalutamide have potential synergistic effects. Further, a significant number of natural compounds effectively target PCa stem cells. However, further high-quality studies are needed to firmly establish the clinical efficacy of these phytochemicals against PCa.

7 months ago

Review • Journal

bicalutamide

7ms

A Systematic Review and Network Meta-Analysis Assessing the Impact of Adding First Generation Non-Steroidal Anti-Androgens (NSAA) to LHRH Agonists (LHRHa) in Men Receiving Radiotherapy for Localized Prostate Cancer. (PubMed, Int J Radiat Oncol Biol Phys)

We did not detect an overall survival benefit to adding NSAA to LHRHa, and NSAA appeared less well tolerated than LHRHa in men receiving radiation therapy for localized prostate cancer. These data suggest that providers should consider LHRHa without the addition of a NSAA as optimal when clinically appropriate.

7 months ago

Clinical • Retrospective data • Review • Journal

bicalutamide

7ms

Castration promotes the browning of the prostate tumor microenvironment. (PubMed, Cell Commun Signal)

Consequently, we concluded that hampering androgen signaling plays a crucial role in the browning of the periprostatic adipose tissue. Also, the presence of brown adipocytes exhibits the opposite effect to that of white adipocytes in vitro regulating processes that govern the mechanisms of cell proliferation of prostate cancer cells. And finally, promoting the browning of adipose tissue in the periprostatic adipose tissue might be a way to handle prostate cancer cell progression. Video Abstract.

7 months ago

Journal

bicalutamide