Media Articles Related to Bicalutamide
Prostate cancer: Astellas announces new enzalutamide data
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.03.26]
Astellas Pharma Europe Ltd. has announced new data from the Phase 2 TERRAIN trial of enzalutamide compared to bicalutamide in metastatic castration-resistant prostate cancer (CRPC), as well as an...
Vitamin D3 May Keep Low-Risk Prostate Cancers in Check
Source: Medscape Today Headlines [2015.03.25]
Vitamin D3. reduced inflammation of the prostate gland after punch biopsy in a small pilot study, and researchers suggest it could keep low-grade cancers from becoming aggressive.
Medscape Medical News
Active Surveillance OK in Intermediate-Risk Prostate Cancer?
Source: Medscape Hematology-Oncology Headlines [2015.03.25]
Dr Gerald Chodak discusses two recent studies that provided support for using active surveillance in certain men with intermediate-risk prostate cancer.
Detecting prostate cancer cells in blood can give an early warning of treatment failure
Source: Blood / Hematology News From Medical News Today [2015.03.25]
A blood test that measures the number of cells shed from prostate tumours into the bloodstream can act as an early warning sign that treatment is not working, a major new study shows.
European experts reveal new survey data that demonstrates a need for increased focus on 'the man behind the prostate cancer'
Source: Prostate / Prostate Cancer News From Medical News Today [2015.03.25]
Astellas Pharma Europe Ltd., in partnership with the Every Moment Matters Steering Committee, today announce results from a new survey of men living with prostate cancer across Europe.
Published Studies Related to 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 Bicalutamide
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 Safety Study of Vandetanib (ZD 6474) in Combination With Bicalutamide Versus Bicalutamide Alone in Patients With Chemotherapy Naive Hormone Refractory Prostate Cancer. [Recruiting]
Purpose To define the efficacy, tolerability and safety of Vandetanib in combination with
bicalutamide in patients with chemotherapy naive hormone refractory prostate cancer
Hypothesis There will be a PSA response when Vandetanib is given in combination with
Bicalutamide in Chemotherapy Naive Hormone refractory prostate cancer patients.
Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic 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. Everolimus may
stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they
work compared with bicalutamide in treating patients with recurrent or metastatic prostate
Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer [Active, not recruiting]
The purpose of this trial is to study the effect - in terms of time to progression and
overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in
subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the
Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy [Completed]
RATIONALE: Drugs used in chemotherapy, such as eflornithine, work in different ways to stop
tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of
prostate cancer cells. Drugs used in hormone therapy, such as bicalutamide, may fight
prostate cancer by stopping the adrenal glands from producing androgens. Combining
eflornithine with bicalutamide may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of neoadjuvant eflornithine
and bicalutamide with that of eflornithine alone, bicalutamide alone, and no neoadjuvant
therapy in treating patients who are undergoing brachytherapy or radical prostatectomy for
localized prostate cancer.
Reports of Suspected Bicalutamide Side Effects
Oedema Peripheral (7),
Cardiac Failure Congestive (6),
Dilatation Ventricular (5),
Prostate Cancer (5),
Vision Blurred (5),
Drug Interaction (4),
Interstitial Lung Disease (4), more >>