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

Sponsor:	Algeta ASA
Collaborator:	Bayer
Information provided by:	Algeta ASA
ClinicalTrials.gov Identifier:	NCT00699751

Purpose

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.

Condition	Intervention	Phase
Hormone Refractory Prostate Cancer Bone Metastases	Drug: Alpharadin (Radium-223) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Algeta ASA:

Primary Outcome Measures:

Overall survival [ Time Frame: Time from date of randomisation to the date of event ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to occurrence of specific disease events [ Time Frame: Time to first on-study specific disease events ] [ Designated as safety issue: Yes ]
Changes and time to progression in PSA [ Time Frame: Study duration ] [ Designated as safety issue: No ]
Changes and time to progression in total-ALP [ Time Frame: Study duration ] [ Designated as safety issue: No ]
Safety endpoints; Adverse events, laboratory values, potential manifestations of late toxicity [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
Clinical benefit endpoints: Performance status, Health related Quality of Life [ Time Frame: Study duration ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Alpharadin plus best standard of care	Drug: Alpharadin (Radium-223) Alpharadin (Radium-223) 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals
Placebo Comparator: 2 Saline solution plus best standard of care	Drug: Placebo Isotonic saline 6 IV administrations separated by 4 weeks intervals

Detailed Description:

The aim of the study is to compare, in patients with symptomatic HRPC and skeletal metastases, the efficacy of best standard of care plus Alpharadin versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).

Patients will be randomised in a 2:1 allocation ratio (Alpharadin:Placebo). The study treatment consists of 6 intravenous administrations of Alpharadin or placebo (saline) each separated by an interval of 4 weeks. The patient will be followed until 3 years after first study drug administration.

Within the U.S., the trial is conducted under an IND sponsored by Bayer HealthCare Pharmaceuticals.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Main inclusion criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate
Known hormone refractory disease
Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy
No intention to use cytotoxic chemotherapy within the next 6 months
Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT for bone pain

Main exclusion criteria:

Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago
Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699751

Show 149 Study Locations

Sponsors and Collaborators

Algeta ASA

Bayer

Investigators

Study Chair:

Christopher Parker, M.D.

The Royal Marsden Hospital, UK

More Information

No publications provided

Responsible Party:	Charles Gillies O'Bryan-Tear/ CMO, Algeta ASA, Oslo, Norway
ClinicalTrials.gov Identifier:	NCT00699751 History of Changes
Other Study ID Numbers:	BC1-06
Study First Received:	June 17, 2008
Last Updated:	September 28, 2011
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Ministry of Social Affairs, Public Health and the Environment; Brazil: Ministry of Health; Canada: Canadian Institutes of Health Research; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hong Kong: Department of Health; India: Ministry of Health; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Singapore: Health Sciences Authority; Spain: Spanish Agency of Medicines; Slovakia: State Institute for Drug Control; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Algeta ASA:

Hormone Refractory Prostate Cancer
Bone Metastases
Radium-223

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms, Second Primary
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms

Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012