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Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure

2014-08-27 03:56:04 | BioPortfolio

Summary

The purpose of this phase II, randomized, double-blind placebo controlled, multi-center study is to evaluate the safety and efficacy of 10 mg atrasentan in hormone naive subjects as measured by rate of rise in the PSA (primary objective).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Prostatic Neoplasms

Intervention

Atrasentan

Location

Urology Centers Of Alabama
Homewood,
Alabama
United States
35205

Status

Completed

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:04-0400

Clinical Trials [379 Associated Clinical Trials listed on BioPortfolio]

Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer

This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.

A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors

The study objective is to investigate the effects of three low doses of atrasentan on urinary albumin/creatinine ratio (UACR) levels in subjects with Type 2 diabetic nephropathy.

Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone

The main purpose of this study is to look at the effects (good or bad) that Atrasentan given alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction in ...

Atrasentan in Treating Patients With Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase III trial to determine the effectiveness of atrasent...

Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of atrasentan in...

PubMed Articles [617 Associated PubMed Articles listed on BioPortfolio]

Evolving concepts in prostatic neuroendocrine manifestations: from focal divergent differentiation to AMPHICRINE carcinoma.

Prostatic neuroendocrine manifestations encompass a heterogeneous spectrum of morphological entities. In the era of evidence-based and precision-led treatment, distinction of biologically relevant cli...

18F-NaF PET/CT in Prostatic Calculi.

Primary prostatic calculi commonly present asymptomatically in men over the age of 50 years. Individual calculi form when the secretory tube is blocked by inflammation, prostatic secretions, or corpor...

Prostatic Artery Embolization versus Standard Surgical Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis.

Prostatic artery embolization (PAE) has been introduced into clinical practice for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS) despite a lack of ...

The UroLift® system for treatment of the benign prostatic syndrome (BPS).

Minimally-invasive treatment options for patients with LUTS due to benign prostatic obstruction (BPO) become more and more important because they provide equal long-term efficacy compared with the ref...

Prostatic capsular incision during radical prostatectomy has important oncological implications. A systematic review and meta-analysis.

Capsular Incision (CapI) is an iatrogenic breach of the prostatic capsule during radical prostatectomy that can cause positive surgical margins (PSM) in organ-confined (pT2) prostate cancer (PCa), or ...

Medical and Biotech [MESH] Definitions

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

Tumors or cancer of the PROSTATE.

A premalignant change arising in the prostatic epithelium, regarded as the most important and most likely precursor of prostatic adenocarcinoma. The neoplasia takes the form of an intra-acinar or ductal proliferation of secretory cells with unequivocal nuclear anaplasia, which corresponds to nuclear grade 2 and 3 invasive prostate cancer.

A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.

Tumors or cancer of the PROSTATE which can grow in the presence of low or residual amount of androgen hormones such as TESTOSTERONE.

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