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A Placebo-Controlled Phase II Study of Bone-Targeted Radium-223 in Symptomatic Hormone-Refractory Prostate Cancer

2014-07-24 14:21:47 | BioPortfolio

Summary

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

Description

Primary objective:

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

Secondary objectives:

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

Study Design

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

Conditions

Prostate Cancer

Intervention

Alpharadin (Radium-223)

Location

Radiumhemmet, Karolinska Hospital
Stockholm
Sweden
SE-17176

Status

Active, not recruiting

Source

Algeta ASA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:21:47-0400

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A Dose Finding Study of Radium-223 for Prostate Cancer Patients With Bone Metastases

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 ...

Radium-223 in Patients With Hormone Refractory Prostate Cancer (HRPC) and Skeletal Metastases

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...

A Phase III Study of Alpharadin (Radium-223)in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

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PubMed Articles [13498 Associated PubMed Articles listed on BioPortfolio]

Is There a Flare Phenomenon on Bone Scintigraphy in Men With Advanced Prostate Cancer Treated With Radium-223?

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...

Clinical case of a patient undergoing radium-223 treatment following treatment with abiraterone acetate and enzalutamide.

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 ...

Radioligand therapy of metastatic castration-resistant prostate cancer: current approaches.

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...

The role of bisphosphonates or denosumab in light of the availability of new therapies for prostate cancer.

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...

The Role of Testosterone Therapy in the Setting of Prostate Cancer.

The role of testosterone in the development of prostate cancer and the safety of testosterone therapy (TTh) after prostate cancer treatment, or in the setting of active surveillance, remains controver...

Medical and Biotech [MESH] Definitions

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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