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Bicalutamide (Bicalutamide) - Summary

 
 



BICALUTAMIDE SUMMARY

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

Bicalutamide Tablets, USP 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, USP 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

A Treatment Vaccine for Low-Risk Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2016.05.20]
A planned phase 2 trial will test a PSA protein-based immunotherapeutic vaccine in men at the time of clinical presentation with early-stage prostate cancer.
Medscape Medical News

Genetic biomarker may predict nerve pain side effects associated with prostate cancer treatment
Source: Pain / Anesthetics News From Medical News Today [2016.05.16]
New study finds genetic alterations in the VAC14 gene are associated with an increased risk of docetaxel-induced peripheral neuropathy in prostate cancer patients.

Radiotherapy halves deaths from prostate cancer 15 years after diagnosis
Source: Endocrinology News From Medical News Today [2016.05.10]
A longitudinal Nordic study, comparing the results of hormone (antiandrogen) therapy with or without the addition of local radiotherapy, shows that a combination of treatments halves the risk of...

Could 'Breast Cancer Genes' Play Role in Prostate Cancer, Too?
Source: MedicineNet Prostate Cancer Specialty [2016.05.10]
Title: Could 'Breast Cancer Genes' Play Role in Prostate Cancer, Too?
Category: Health News
Created: 5/9/2016 12:00:00 AM
Last Editorial Review: 5/10/2016 12:00:00 AM

BRCA gene mutations associated with increased prostate cancer risk
Source: Prostate / Prostate Cancer News From Medical News Today [2016.05.09]
Though predominantly known for their increased associations with breast cancer risk, germline mutations in the BRCA1 and BRCA2 genes are also associated with an increased susceptibility to other...

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.

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Clinical Trials Related to Bicalutamide

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.

Dose Finding Study of BKM 120 in Combination With LH-RH Agonists and Bicalutamide in Men With Non Castrate Metastatic Prostate Cancer [Recruiting]
To determine the maximum-tolerated dose (MTD) of BKM120 when administered orally in combination with daily bicalutamide and LH-RH agonists to men with non castrate metastatic prostate cancer.

RAD001 and Bicalutamide for Androgen Independent Prostate Cancer [Terminated]
The goal of this clinical trial is to learn if the study drug RAD001 in combination with Bicalutamide can slow the growth of prostate cancer. The safety of RAD001 given together with Bicalutamide will also be studied. RAD001 has been shown to kill prostate cancer cells. In addition, several hundred kidney and heart transplant patients have been treated with the same main ingredient as in RAD001 for many years.

Pazopanib Hydrochloride With or Without Bicalutamide in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy [Active, not recruiting]
This randomized phase II trial is studying how well giving pazopanib with or without bicalutamide works in treating patients with prostate cancer that did not respond to hormone therapy. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Giving pazopanib hydrochloride together with bicalutamide may be an effective treatment for prostate cancer.

Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer [Active, not 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.

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: 2016-05-20

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