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Bicalutamide (Bicalutamide) - Summary

 
 



BICALUTAMIDE SUMMARY

Bicalutamide tablets contain 50 mg of bicalutamide USP, a non-steroidal androgen receptor inhibitor with no other known endocrine activity.

Bicalutamide tablets 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.

Bicalutamide tablets 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies].


See all Bicalutamide indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Bicalutamide

Blood Tests May Define Why Treatment Fails in Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2014.09.25]
A new study has shown how genomic analysis of repeated sampling of biopsies and blood samples may provide a new 'treatment paradigm' in the future.
Medscape Medical News

High-Dose RT Is a 'Conundrum' in Localized Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2014.09.24]
A major phase 3 trial compared high- and standard-dose radiation therapy in intermediate-risk, localized disease. The results cast doubt on the dose that American practitioners most commonly use.
Medscape Medical News

Should Higher Risk = Earlier Screening for Prostate Cancer?
Source: Medscape Family Medicine Headlines [2014.09.23]
Dr. Gerald Chodak discusses a new study that looked for the best way to screen for prostate cancer in African American men and those with a family history of prostate cancer.
Medscape Urology

Pioneering Trial of Radiation in Aggressive Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2014.09.23]
Patients with high-risk prostate cancer should be treated with long-term hormone therapy and high-dose radiation, a new study concludes.
Medscape Medical News

Sexual function preserved following vessel-sparing radiation therapy for prostate cancer
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2014.09.19]
A comparison of five-year sexual function outcomes, as reported by patients treated with external beam radiotherapy (EBRT) versus combination EBRT plus brachytherapy, indicates that the utilization...

more news >>

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.

more studies >>

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 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 brachytherapy.

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 cancer.

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 prostate gland.

more trials >>

Reports of Suspected Bicalutamide Side Effects

Oedema Peripheral (7)Cardiomegaly (6)Cardiac Failure Congestive (6)Dyspnoea (6)Dilatation Ventricular (5)Prostate Cancer (5)Scotoma (5)Vision Blurred (5)Drug Interaction (4)Interstitial Lung Disease (4)more >>


Page last updated: 2014-09-25

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