Media Articles Related to Casodex (Bicalutamide)
New ASCO Guideline for Castration-Resistant Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2014.09.11]
Treatment choices with systemic therapies have increased for men with metastatic castration-resistant prostate cancer. The American Association of Clinical Oncology and Cancer Care Ontario have joined hands to issue their own guideline for these patients.
Medscape Medical News
New guidelines that favor watchful waiting in prostate cancer may not be suitable for African Americans
Source: Prostate / Prostate Cancer News From Medical News Today [2014.09.10]
There is an active controversy among oncologists about when to treat prostate cancer patients, with some suggesting that the word "cancer" be removed from the description of low grade disease, in...
Enzalutamide significantly reduces morbidities associated with bone metastases in men with metastatic castration-resistant prostate cancer
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.09.09]
Enzalutamide (XTANDI™) reduces the risk of skeletal-related events compared with placebo, as well as reducing pain and increasing quality of life in men with metastatic castration-resistant...
New Guidelines for Treating Advanced Prostate Cancer
Source: MedicineNet Clinical Trials Specialty [2014.09.09]
Title: New Guidelines for Treating Advanced Prostate Cancer
Category: Health News
Created: 9/8/2014 4:36:00 PM
Last Editorial Review: 9/9/2014 12:00:00 AM
Watchful Waiting May Not Be Best for Black Men With Prostate Cancer
Source: MedicineNet Prostate Cancer Specialty [2014.09.09]
Title: Watchful Waiting May Not Be Best for Black Men With Prostate Cancer
Category: Health News
Created: 9/8/2014 4:36:00 PM
Last Editorial Review: 9/9/2014 12:00:00 AM
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.
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.
Casodex - Nolvadex Combination [Completed]
This study looks at the relationship in the dose of nolvadex and the incidence of
gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with
Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the
breast tissue adverse effects without reducing the efficacy of Casodex.
Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer [No longer available]
This study provides compassionate use of bicalutamide (Casodex) at a 150-mg dose for subjects
with prostate cancer prior to it becoming commercially available. The patient will receive
bicalutamide 150-mg as long as the physician feels that the subject is benefiting from this
therapy and safety information is provided regularly to AstraZeneca. Treatment will be
discontinued after bicalutamide 150-mg becomes commercially available.
Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer [Recruiting]
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy,
such as bicalutamide, may lessen the amount of androgens made by the body. Selective
estrogen receptor modulators, such as raloxifene, may work together with bicalutamide to
stop the growth of prostate cancer.
PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating
patients with metastatic or hormone-refractory prostate cancer.
Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy [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
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 >>