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Casodex (Bicalutamide) - Summary



CASODEX® (bicalutamide) Tablets for oral administration contain 50 mg of bicalutamide, a non-steroidal antiandrogen with no other known endocrine activity. The chemical name is propanamide, N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-,(+-). The structural and empirical formulas are:

CASODEX is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analogue for the treatment of Stage D2 metastatic carcinoma of the prostate.

See all Casodex indications & dosage >>


Media Articles Related to Casodex (Bicalutamide)

Prostate Cancer
Source: MedicineNet Prostate Cancer Specialty [2015.10.07]
Title: Prostate Cancer
Category: Symptoms and Signs
Created: 10/7/2015 12:00:00 AM
Last Editorial Review: 10/7/2015 12:00:00 AM

UTMB study shows testosterone therapy does not increase aggressive prostate cancer risk
Source: Endocrinology News From Medical News Today [2015.10.06]
A new population-based study from The University of Texas Medical Branch at Galveston showed for the first time that exposure to testosterone therapy over a five-year period was not associated with...

International agreement on MRI-scans 'likely to change how we detect prostate cancer'
Source: MRI / PET / Ultrasound News From Medical News Today [2015.10.02]
International radiological bodies* have agreed on a standard for how doctors evaluate MRI to confirm a diagnosis of prostate cancer.

New prostate cancer treatments could target metabolism
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.09.30]
Prostate cancer is the most commonly diagnosed malignancy and second leading cause of cancer-related deaths among men in the U.S.

Risk factors for prostate cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2015.09.30]
New research suggests that age, race and family history are the biggest risk factors for a man to develop prostate cancer, although high blood pressure, high cholesterol, vitamin D deficiency...

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Published Studies Related to Casodex (Bicalutamide)

Relative bioavailability and tolerability of two formulations of bicalutamide 50-mg tablets: a randomized-sequence, open-label, two-period crossover study in healthy Korean male subjects. [2010.12]
BACKGROUND: Bicalutamide is an oral nonsteroidal antiandrogenic drug used in the treatment of prostate cancer. A new generic 50-mg tablet formulation of bicalutamide has recently been developed. OBJECTIVE: This study evaluated the relative bioavailability and tolerability of the new generic formulation of bicalutamide 50-mg tablets (test) and the currently marketed formulation (reference) in healthy Korean male subjects. The study was conducted to meet Korean regulatory requirements for authorization to market the generic formulation... CONCLUSIONS: In this single-dose study in healthy Korean male subjects, the pharmacokinetic parameters of the new generic formulation of bicalutamide 50-mg tablets did not differ significantly from those of the reference formulation. The new generic formulation met Korean regulatory criteria for the assumption of bioequivalence to the currently marketed formulation. Both formulations were well tolerated. Korea Food and Drug Administration registration number: PSPD 3057. Copyright (c) 2010 Elsevier HS Journals, Inc. All rights reserved.

An open, randomised, multicentre, phase 3 trial comparing the efficacy of two tamoxifen schedules in preventing gynaecomastia induced by bicalutamide monotherapy in prostate cancer patients. [2010.02]
BACKGROUND: Bicalutamide monotherapy is a valuable option for prostate cancer (PCa) patients who wish to avoid the consequences of androgen deprivation; however, this treatment induces gynaecomastia and mastalgia in most patients. Tamoxifen is safe and effective in preventing breast events induced by bicalutamide monotherapy without affecting antitumor activity, but possible interference between bicalutamide and tamoxifen remains a matter of concern. To reduce the exposure to tamoxifen, we considered the putative advantages of weekly administration. OBJECTIVE: To compare the efficacy of two different schedules of tamoxifen in preventing breast events. Toxicity, prostate-specific antigen behaviour, and sexual-functioning scores were also evaluated... CONCLUSIONS: This study demonstrated that tamoxifen 20mg/wk is inferior to tamoxifen 20mg/d in preventing the incidence and severity of bicalutamide-induced breast events. The safety and efficacy of tamoxifen at the common daily dose of 20mg for the prophylaxis of bicalutamide-induced breast events were confirmed. Copyright 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Comparative pharmacokinetic evaluation of two formulations of bicalutamide 50-mg tablets: an open-label, randomized-sequence, single-dose, two-period crossover study in healthy Korean male volunteers. [2009.12]
BACKGROUND: Bicalutamide is an oral nonsteroidal antiandrogen drug used during hormone ablation therapy for prostate cancer. A new generic formulation of bicalutamide has been developed... Both formulations were generally well tolerated, with no clinically relevant safety concerns.

Combined androgen blockade with bicalutamide for advanced prostate cancer: long-term follow-up of a phase 3, double-blind, randomized study for survival. [2009.08.01]
BACKGROUND: A previously reported, double-blind, randomized, multicenter phase 3 trial in 205 patients with stage C/D prostate cancer compared combined androgen blockade (CAB) with luteinizing hormone-releasing hormone agonist (LHRH-A) plus bicalutamide 80 mg versus LHRH-A plus bicalutamide-matching placebo (LHRH-A monotherapy). The analysis at a median follow-up of 2.4 years indicated that CAB significantly (P<.001) prolonged the time to progression and the time to treatment failure. In the current report, survival data from a long-term follow-up (median, 5.2 years) were analyzed... CONCLUSIONS: CAB with bicalutamide 80 mg offered a significant overall survival benefit compared with LHRH-A monotherapy without reducing tolerability in patients with locally advanced or metastatic prostate cancer. Copyright (c) 2009 American Cancer Society.

Phase I-II trial of weekly bicalutamide in men with elevated prostate-specific antigen and negative prostate biopsies. [2009.04]
BACKGROUND: Men with elevated prostate-specific antigen (PSA) and negative prostate biopsies are at risk for prostate cancer. The antiandrogen bicalutamide has a prolonged half-life, thus potentially allowing an intermittent administration to retain activity while reducing toxicity. We conducted a phase I-II trial of weekly bicalutamide in men with PSA >4 ng/mL and negative biopsies... CONCLUSIONS: A weekly administration of bicalutamide seems to be reasonably safe and shows an encouraging signal of activity on HG-PIN prevalence, supporting further studies of this schedule in men at high risk despite the negative primary end-point findings on Ki-67.

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Clinical Trials Related to Casodex (Bicalutamide)

Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX [Completed]
The primary objective of this trial is to examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain. Patients will receive either prophylactic radiotherapy to the breast at a dose of 12Gy (as two fractions of 6 Gy in consecutives days), or will not receive any radiotherapy prior to commencing CASODEX 150mg monotherapy.

Treatment Protocol to Monitor the Safety of a 200 mg Dose of Bicalutamide in Patients With Advanced Prostate Cancer [Completed]
This is an open label, single-centered treatment protocol designed to monitor the safety of patients treated with a 200 mg daily dose of CASODEX. Patient will receive CASODEX as long as physician feels that he is benefiting from this form of therapy.

Bioequivalence of Bicalutamide New Formulation in Japan [Terminated]
The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects

Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex® 50 mg Tablet in Healthy Subjects Under Fed Conditions [Completed]

Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy [Active, not recruiting]
The purpose of this study is to determine if a combination of neoadjuvant dutasteride and bicalutamide has the same efficacy and less toxicity than standard treatment with an LHRH agonist and bicalutamide for prostate cytoreduction prior to permanent implant brachytherapy.

more trials >>

Reports of Suspected Casodex (Bicalutamide) Side Effects

Hepatic Function Abnormal (12)Interstitial Lung Disease (10)Renal Impairment (9)Prostate Cancer (7)Cerebral Infarction (7)Platelet Count Decreased (7)Cardiac Failure (6)Pulmonary Embolism (5)Disseminated Intravascular Coagulation (4)Suicidal Ideation (4)more >>

Page last updated: 2015-10-07

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