Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Androgen Antagonists

Bicalutamide

Hormones

Hormone Antagonists

Placebo

William See

David G. McLeod

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.

Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer

A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.

AstraZeneca

Symptoms and General Pathology

Gland and Hormone Related Diseases

Syndrome

Inflammation

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

Natriuretic Agents

Reproductive Control Agents

Metformin

Spironolactone

Pioglitazone

Complement System Proteins

Ethinyl Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

2,4-thiazolidinedione

Cyproterone Acetate

Cyproterone

Mineralocorticoid Receptor Antagonists

Mineralocorticoids

Diuretics

Diuretics, Potassium Sparing

Contraceptive Agents

Contraceptive Agents, Male

Cyproterone compound (Cyproterone acetate 2mg+Ethinyl estradiol 35 mcg) once daily + Spironolactone 50 mg twice daily

Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily

Cyproterone compound + Spironolactone

Mesbah Shams, MD

Gholamhossein R Omrani, MD

The aim of this study is to evaluate the effects of three-month course of treatment modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with polycystic ovary syndrome (PCOS) on markers of inflammation \[serum complement, homocysteine and high sensitive C-reactive protein (hs-CRP)\] levels.

Polycystic ovary syndrome (PCOS) is estimated to affect up to10% of women of reproductive age, making it one of the most common endocrine disorders in this population. PCOS is associated with a broad range of adverse sequel, including hypertension, dyslipidemia, insulin resistance, hyperandrogenaemia, gestational and type 2 diabetes,which ultimately increase the cardiovascular morbidity in these patients. Also PCOS is increasingly recognized as a component of the metabolic syndrome. Management depends on symptoms or the source of androgen excess. Several treatment options are available, which allows for an individualized approach. Spironolactone is the safest potent available antiandrogen. It is effective in lowering the hirsutism score by approximately one third, although considerable individual variations exist. Other antiandrogens used to treat hirsutism and hirsutism equivalents include cyproterone acetate that has weak antiglucocorticoid effects. Metformin and thiazolidinediones, are promising adjuncts for treating PCOS. Although both of them increase insulin sensitivity, but their mechanism of action differ.

Serum complement, homocysteine and C-reactive protein (CRP) levels have been reported to be linked with insulin resistance.

The investigators want to measure serum complement, homocysteine and hs-CRP levels in patients with PCOS before and after three-month course of treatment with Cyproterone compound-Spironolactone (CC-S), metformin (M) and pioglitazone (P).

Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS

Effects of Treatment With Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Serum Inflammatory Markers in Patients With Polycystic Ovary Syndrome (PCOS)

Serum concentration of a component of complement cascade: C3

Serum concentration of a component of complement cascade: C4

Serum concentration of high-sensitive C-reactive protein (hs-CRP)

Serum concentration of total Testosterone

Serum concentration of Dehydroepiandrosterone sulfate

Serum concentration of follicle stimulating hormone

Serum concentration of luteinizing hormone

Shiraz University of Medical Sciences

Associate professor of internal medicine and endocrinology

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Estrogens

Progesterone

Androgen Receptor Antagonists

This is a multi-center, open-label, phase II study to evaluate the anti-tumor activity and safety of bicalutamide administered orally daily to patients with estrogen receptor (ER)-negative/ progesterone receptor (PgR)-negative/ androgen receptor (AR)-positive metastatic breast cancer. Eligible patients will receive bicalutamide at a dose of 150mg PO daily.

Treatment of the Physician's Choice defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy, administered according to local practice, if applicable

Patients in experimental group are designated to take bicalutamide orally, 150mg on a continuous schedule. The investigator should pay attention to the patients' adverse event. Every month, the patients will be evaluated for the adverse event by the criterion National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0. Every 2 months, the patients will be evaluated for the clinical effects. If disease progressed, the patients would be ruled out.

Treatment continued until disease progression, unacceptable toxic effects, patient or physician request to discontinue, or serious protocol non-compliance. A maximum of 2 dose reductions for grade \>= 3 toxicity were allowed (100 and 50 mg). A maximum of 2 weeks was permitted for treatment delays due to toxicity.

The comparator group, treatment of physician's choice (TPC), represented a mix of agents (both approved and non-approved for metastatic breast cancer) to mirror clinical practice at the time in this setting.

The 60 patients are enrolled in the study, before randomized to the two arms, each of them will be assessed for eligibility and then their proposed TPC.

Treatment continued until disease progression, unacceptable toxic effects, patient or physician request to discontinue, or serious protocol non-compliance.

Physician's Choice

Xiaoxiang Guan, MD; PhD

Growing studies demonstrated that Androgen Receptor (AR) has an oncogenic role for the patients with AR-positive Triple Negative Breast Cancer (TNBC). AR antagonists in therapy, such as bicalutamide, completely binds to the AR, increasing AR degradation, thus are investigated for the efficacy of the treatment of patients with AR-positive TNBC in the study.

More than 70% of human breast cancers express the androgen receptor (AR), and in retrospective analysis, the expression of AR in Triple-Negative Breast Cancer (TNBC) varies from 10-43%. Recently emerging preclinical and clinical data suggest that AR may play a role in tumor proliferation. For example, Hu et al (2011) analyzed AR expression in 211 TNBC cases. He found that AR is related with an 83% increase in overall mortality, when compared with AR-negative TNBC. McGhan et al (2014) also found that AR expression tends to exist in TNBC patients with higher tumor stage and lymph metastases.

The role of AR has also been extensively studied in vitro. With targeting AR with small interfering RNA (siRNA) and treatment with anti-androgen bicalutamide, studies showed that AR has a proliferative role in TNBC cells. Robinson et al (2011) also clarified that AR can mimic estrogen receptor α (ERα) in a transcriptionally active manner directed by the forkhead box protein A1 (FoxA1). These indicate that, in ER-negative disease, AR can promote tumor progression, therefore, could serve as a therapeutic target in TNBC.

Due to the demonstration of oncogenic role for the AR in TNBC, clinical trials are underway to study the role of inhibiting androgen signaling for the treatment for TNBC. For example, Gucalp et al (2013) performed a sing-arm phase II study to investigate the role of bicalutamide in AR-positive TNBC. A total of 26 patients were enrolled in the study, and the study demonstrated a general well tolerated effect and a 6-month clinical benefit rate of 19%. Furthermore, future clinical trials are also designed to show the anti-androgen therapy such as Enzalutamide, the 17alpha-hydroxylase/C(17,20)-lyase inhibitor abiraterone acetate and orteronel for AR-positive TNBC. This study is investigated to study the role of bicalutamide for AR-positive TNBC, and it may help clarify the effect of bicalutamide for the specific breast cancer subtype. Furthermore, it may provide an additional therapy to treat the difficult to treat population.

AR-inhibitor Bicalutamide in Treating Patients With TNBC

Bicalutamide in Treating Patients With AR-positive Metastatic Triple Negative Breast Cancer

The proportion of stability, partial response and complete response in patients who receive bicalutamide as second-, or third-line therapy for estrogen receptor (ER)/ progesterone receptor (PgR)-negative, human epidermal growth factor receptor (HER-2)-negative and AR-positive Metastatic Breast Cancer

FACT(Functional Assessment of Cancer Therapy) -B :a 36-item compilation, subdivided into four primary QOL (Quality of life) domains and a disease specific domain - additional concerns for breast cancer

Wenzhou Medical University

The First People's Hospital of Lianyungang

Wuxi People's Hospital

Nanning Second People's Hospital

Jiangsu Province Hospital of Traditional Chinese Medicine

The Second Hospital of Nanjing Medical University

Jinling Hospital, China

Peter Iversen, MD

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.

Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.

Scandinavian Prostate Cancer Group

Dr Tom Morris

Manfred P Wirth, Professor

(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer

A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer

Dr. Tom Morris

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer	NCT00657904	Non-metastatic ...	Bicalutamide Placebo	18 Years -	AstraZeneca
Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS	NCT02689843	Polycystic Ovar...	Cyproterone com... Metformin Pioglitazone	18 Years - 35 Years	Shiraz University of Medical Sciences
Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer	NCT00657904	Non-metastatic ...	Bicalutamide Placebo	18 Years -	AstraZeneca
AR-inhibitor Bicalutamide in Treating Patients With TNBC	NCT02353988	Breast Neoplasm...	Bicalutamide Physician's Cho...	18 Years - 70 Years	Jinling Hospital, China
Casodex vs Placebo in Non-Metastatic Early Prostate Cancer	NCT00672282	Non-Metastatic ...	Bicalutamide Placebo	18 Years -	AstraZeneca
(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer	NCT00673205	Non-Metastatic ...	Bicalutamide Placebo	18 Years -	AstraZeneca
Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS	NCT02689843	Polycystic Ovar...	Cyproterone com... Metformin Pioglitazone	18 Years - 35 Years	Shiraz University of Medical Sciences

Spots Global Cancer Trial Database for androgen antagonists