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The purpose of this study is to evaluate the effictiveness of the investigational radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment
To study the biological effectiveness of radium-223 therapy measured as
- Time to occurrence of skeletal-related events(SREs)
- Change in bone-specific alkaline phosphatase (bone-ALP) levels
To study the efficacy of radium-223 therapy in terms of:
- Frequency of new SREs
- Proportions of patients with an SRE
- Proportions of patients with SRE at different time points
- Changes of biochemical markers of bone turnover
- Treatment response with regard to pain and analgesic use(termed "Palliative effect" in study protocol)
- Quality of life assessment
- Overall survival
To study the safety of the repeated radium-223 regimen.
Total Enrollment:64 Study start: February 2004
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Radiumhemmet, Karolinska Hospital
Active, not recruiting
Published on BioPortfolio: 2014-07-24T14:21:47-0400
The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone metastases that no ...
The purpose of this study is to evaluate the biodistribution, radiation dosimetry, pharmacokinetics and safety of the investigational radioisotope Radium-223, Alpharadin, in men with prost...
Alsympca is an international Phase III clinical study to evaluate the efficacy and safety of Alpharadin, in patients with hormone refractory prostate cancer and skeletal metastases.
The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of three intravenous escalating dose levels of Alpharadin.
The main purpose of this study is to establish a recommended dose of Alpharadin® to be used in combination with docetaxel in patients with bone metastases from castration-resistant prosta...
Radium-223 is an approved survival-prolonging treatment option in men with castration-resistant prostate cancer (mCRPC) and bone metastases. In the registration trial (ALSYMPCA), no regular imaging wa...
Radium 223 was introduced for metastatic castration-resistant prostate cancer based on the results of a randomized controlled trial showing risk reduction for death and skeletal events. Our aim was to...
Over the last decade, significant advances have been made in the development of therapies for patients with metastatic castration-resistant prostate cancer. Abiraterone and enzalutamide were approved ...
Prostate Cancer is the forth most common type of cancer. Prostate-specific membrane antigen (PSMA) is anchored in the cell membrane of prostate epithelial cells. PSMA is highly expressed on prostate e...
Most men with advanced prostate cancer will develop bone metastases, which have a substantial impact on quality of life. Bone metastases can lead to skeletal-related events (SREs), which place a burde...
A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
Radium. A radioactive element of the alkaline earth series of metals. It has the atomic symbol Ra, atomic number 88, and atomic weight 226. Radium is the product of the disintegration of uranium and is present in pitchblende and all ores containing uranium. It is used clinically as a source of beta and gamma-rays in radiotherapy, particularly BRACHYTHERAPY.
A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.
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).
Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.
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Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...