Bicalutamide

Generic Name: Bicalutamide

Brand Names: Casodex

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₁₄F_₄N_₂O_₄S

CAS Number: 90357-06-5

Unique Ingredient Identifier: A0Z3NAU9DP

Background: Bicalutamide is an oral non-steroidal anti-androgen for prostate cancer. It is comprised of a racemic mixture that is a 50:50 composition of the (R)-bicalutamide and (S)-bicalutamide enantionmers. Bicalutamide binds to the androgen receptor.

Indication: Bicalutamide is indicated in combination with a luteinizing hormone-releasing hormone (LHRH) agonist for the treatment of Stage D2 metastatic carcinoma of the prostate.

Associated Conditions: Metastatic stage D2 Prostatic carcinoma

Associated Therapies: -

Clinical Trials

REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial

Phase 3

Not yet recruiting

Conditions: Recurrent Prostate Carcinoma
Stage III Prostate Cancer AJCC V8
Stage IVA Prostate Cancer AJCC V8

Interventions: Drug: Abiraterone Acetate
Drug: Bicalutamide
Procedure: Biospecimen Collection
Procedure: Computed Tomography Angiography
Drug: Leuprolide
Drug: Prednisone
Drug: Relugolix
Radiation: Radiation Therapy

First Posted Date: 2024-10-21

Last Posted Date: 2024-10-23

Lead Sponsor: Emory University

Target Recruit Count: 72

Registration Number: NCT06650579

Locations: 🇺🇸
Emory Proton Therapy Center, Atlanta, Georgia, United States
🇺🇸
Winship at Emory Midtown, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

and more 1 locations

Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer

Phase 2

Not yet recruiting

Conditions: High Risk Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Localized Prostate Adenocarcinoma

Interventions: Drug: Gonadotropin Releasing Hormone Agonists and Antagonists
Drug: Bicalutamide
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Other: Questionnaire Administration
Radiation: Radiation Therapy
Procedure: Bone Scan

First Posted Date: 2024-07-30

Last Posted Date: 2024-07-30

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 32

Registration Number: NCT06528210

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma

Phase 1

Not yet recruiting

Conditions: Recurrent Glioblastoma
Recurrent High-grade Glioma

Interventions: Drug: Bicalutamide
Radiation: Intensity-modulated radiation therapy (IMRT)

First Posted Date: 2024-07-15

Last Posted Date: 2024-11-05

Lead Sponsor: University of Nebraska

Target Recruit Count: 30

Registration Number: NCT06501911

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

Phase 2

Recruiting

Conditions: Triple Negative Breast Neoplasms

Interventions: Drug: Abemaciclib
Drug: Bicalutamide

First Posted Date: 2024-04-15

Last Posted Date: 2024-12-11

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 53

Registration Number: NCT06365788

Locations: 🇧🇪
Antwerp University Hospital, Antwerp, Belgium
🇧🇪
Gasthuiszusters Antwerpen, Antwerp, Belgium
🇧🇪
University Hospital Brussels, Brussel, Belgium

and more 3 locations

A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer

Phase 2

Recruiting

Conditions: Non-Muscle Invasive Bladder Cancer

Interventions: Biological: Control Arm
Drug: Bicalutamide

First Posted Date: 2022-04-14

Last Posted Date: 2024-08-21

Lead Sponsor: CHU de Quebec-Universite Laval

Target Recruit Count: 160

Registration Number: NCT05327647

Locations: 🇨🇦
London Health Sciences Centre, London, Ontario, Canada
🇨🇦
Centre intégré universitaire de santé et services sociaux du Saguenay-Lac-Saint-Jean, Chicoutimi, Quebec, Canada
🇨🇦
University Health Network, Princess Margaret Cancer Centre, Toronto, Ontario, Canada

and more 4 locations

Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Phase 1

Recruiting

Conditions: Breast Cancer
Metastasis

Interventions: Drug: Abemaciclib
Drug: Bicalutamide

First Posted Date: 2021-10-27

Last Posted Date: 2024-02-21

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Target Recruit Count: 60

Registration Number: NCT05095207

Locations: 🇺🇸
Mount Sinai Beth Israel, New York, New York, United States
🇺🇸
Mount Sinai - West, New York, New York, United States
🇺🇸
Dubin breast Center, New York, New York, United States

Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer（MAPS）

Conditions: Salivary Gland Neoplasms

Interventions: Drug: Pyrotinib
Drug: Bicalutamide
Drug: Leuprorelin

First Posted Date: 2021-10-21

Last Posted Date: 2021-10-21

Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Target Recruit Count: 182

Registration Number: NCT05087706

Locations: 🇨🇳
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, Shanghai, China

Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score

Phase 3

Recruiting

Conditions: Prostate Adenocarcinoma

Interventions: Drug: Bicalutamide
Drug: Buserelin
Drug: Darolutamide
Drug: Degarelix
Drug: Flutamide
Drug: Goserelin
Drug: Histrelin
Radiation: Radiation Therapy
Drug: Leuprolide
Drug: Relugolix
Drug: Triptorelin

First Posted Date: 2021-09-20

Last Posted Date: 2024-11-27

Lead Sponsor: NRG Oncology

Target Recruit Count: 2050

Registration Number: NCT05050084

Locations: 🇺🇸
Arizona Center for Cancer Care - Gilbert, Gilbert, Arizona, United States
🇺🇸
Arizona Center for Cancer Care-Peoria, Peoria, Arizona, United States
🇺🇸
Arizona Center for Cancer Care - Phoenix, Phoenix, Arizona, United States

and more 532 locations

Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer

Phase 1

Recruiting

Conditions: Prostate Adenocarcinoma

Interventions: Drug: bicalutamide
Radiation: Stereotactic body radiation therapy

First Posted Date: 2021-06-29

Last Posted Date: 2024-01-12

Lead Sponsor: Alessa Therapeutics Inc.

Target Recruit Count: 20

Registration Number: NCT04943536

Locations: 🇺🇸
National Cancer Institute, Bethesda, Maryland, United States

Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer

Phase 2

Recruiting

Conditions: Stage IVB Prostate Cancer AJCC v8
Castration-Sensitive Prostate Carcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Metastatic Prostate Adenocarcinoma

Interventions: Drug: Abiraterone Acetate
Drug: Bicalutamide
Drug: Degarelix
Drug: Goserelin Acetate
Drug: Leuprolide Acetate
Drug: Prednisone
Other: Questionnaire Administration
Drug: Talazoparib

First Posted Date: 2021-02-02

Last Posted Date: 2024-01-03

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 70

Registration Number: NCT04734730

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

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