NEWS HIGHLIGHTSMedia Articles Related to Bicalutamide
Tulane Cancer Center To Begin Novel Clinical Trial For Late-Stage Prostate Cancer Drug
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.18]
International prostate cancer expert Dr. Oliver Sartor of Tulane Cancer Center is the first oncologist in the United States to offer patients an experimental new treatment for late-stage prostate cancer through a multi-center clinical trial that is currently recruiting patients at 100 sites across 20 countries worldwide.
Hollis-Eden Presents New Interim Data From Prostate Cancer Phase I/II Clinical Studies Of Apoptone (HE3235) At AACR Molecular Targets Conference
Source: Conferences News From Medical News Today [2009.11.17]
Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH), reported preliminary results of its ongoing Phase I/II clinical trial with Apoptone® (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC).
Anxiety And Distress During Active Surveillance For Early Prostate Cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.16]
UroToday.com - The present study found that the majority of men with early prostate cancer (PC) included in a protocol-based program for active surveillance (AS) show favorable anxiety and distress scores when compared to reference values and to groups of patients with PC who underwent other treatments.
Percentage Of Positive Biopsy Cores At The Onset Of Hormone Therapy For Prostate Cancer: Prognostic Significance
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.16]
UroToday.com - Accurate prediction of outcome after hormonal treatment for localized prostate cancer is important for patient counselling, follow-up, treatment planning and research protocol design. Few prognostic tools incorporating pre-therapeutic parameters are available to increase disease relapse predictions and survival.
Degarelix: A New Approach For The Treatment Of Prostate Cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.16]
UroToday.com - Gonadotrophin-releasing hormone (GnRH) agonists are currently the 'standard of care' for androgen deprivation therapy (ADT) in prostate cancer. Improvements in ADT would have a great value for many patients. The agonists are associated with an initial testosterone surge, which delays castration and may stimulate tumor growth and induce 'clinical flare' in patients with symptomatic advanced disease.
Published Studies Related to Bicalutamide
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.
Surgical and biologic outcomes after neoadjuvant bicalutamide treatment in prostate cancer. [2007.10]
OBJECTIVES: To perform a randomized, prospective, controlled, intention-to-treat study to determine the usefulness of bicalutamide as a neoadjuvant hormonal therapy regimen to surgery in reducing positive surgical margins and modulating epidermal growth factor receptor (EGFR) member's in men with prostate cancer... CONCLUSIONS: Bicalutamide appears to reduce the prevalence of positive surgical margins. The upregulation of Her2/neu and EGFR and their phosphorylated forms was an early event after bicalutamide treatment. We hypothesized that the benefits of neoadjuvant hormonal therapy might be overwhelmed by the capacity of the residual tumor to acquire compensatory survival pathways and to grow and progress.
Tamoxifen as prophylaxis for prevention of gynaecomastia and breast pain associated with bicalutamide 150 mg monotherapy in patients with prostate cancer: a randomised, placebo-controlled, dose-response study. [2007.07]
OBJECTIVE: To define the optimum tamoxifen dose for reducing bicalutamide (CASODEX) 150 mg monotherapy-induced breast events (ie, gynaecomastia or breast pain or both) without compromising disease control... CONCLUSION: These findings suggest that prophylactic tamoxifen 20 mg/d is an effective dose for reduction of bicalutamide-induced breast events and does not appear to affect disease control based on PSA suppression.
Bicalutamide 80 mg combined with a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A monotherapy in advanced prostate cancer: findings from a phase III randomized, double-blind, multicenter trial in Japanese patients. [2007]
To compare combination therapy with bicalutamide 80 mg and a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A alone in Japanese men with untreated advanced prostate cancer. A total of 205 patients with stage C/D prostate cancer were randomized to either LHRH-A+once-daily oral bicalutamide 80 mg or placebo.
Clinical Trials Related to Bicalutamide
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.
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.
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.
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.
(Bicalutamide) Casodex vs Placebo in Non-Metastatic Early Prostate Cancer [Active, not recruiting]
The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy,
versus placebo, in subjects who have either undergone a primary therapy (principally radical
prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.
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