Media Articles Related to Casodex (Bicalutamide)
Enzalutamide demonstrates statistically significant improvement in progression free survival compared with bicalutamide in Strive trial
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.04.08]
Astellas Pharma Inc. and Medivation, Inc. have announced topline results from the Phase 2 STRIVE trial comparing enzalutamide with bicalutamide in a study population of men with non-metastatic or...
Prostate cancer: Astellas announces new enzalutamide data
Source: Prostate / Prostate Cancer 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...
African-American men at greater risk of prostate cancer, study finds
Source: Cancer / Oncology News From Medical News Today [2015.04.17]
Compared with non-Hispanic white men, obesity presented a higher prostate cancer risk and may be 'uniquely harmful' to African-American men, a new study finds.
Obesity Linked to Greater Risk of Prostate Cancer in Blacks, Study Says
Source: MedicineNet Obesity (Weight Loss) Specialty [2015.04.17]
Title: Obesity Linked to Greater Risk of Prostate Cancer in Blacks, Study Says
Category: Health News
Created: 4/16/2015 12:00:00 AM
Last Editorial Review: 4/17/2015 12:00:00 AM
Walking Boosts Outcomes for Prostate Cancer Survivors
Source: MedicineNet Prostate Cancer Specialty [2015.04.17]
Title: Walking Boosts Outcomes for Prostate Cancer Survivors
Category: Health News
Created: 4/16/2015 12:00:00 AM
Last Editorial Review: 4/17/2015 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.
CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer [Recruiting]
The current protocol will evaluate the safety of combining treatment with
bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with
PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study
with safety the primary endpoint. Secondary endpoints will be to determine whether prostate
associated immune responses are seen, and whether treatment is associated with an increase
in PSA doubling time and PSA recurrence at one year, as markers of clinical activity.
Cohorts of six patients will be treated in each dose level. The investigators hypothesize
that short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell
mediated tissue destruction that can be augmented with a monoclonal antibody blocking
CTLA-4, and that this will have therapeutic benefit in patients with recurrent prostate
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 >>