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

Sponsored by:	Algeta ASA
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

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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:	750
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator 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.

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
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

Contacts

Contact: Bjørg Bolstad	+47 23 00 79 90	bjorg.bolstad@algeta.com
Contact: Ingvild Haugen	+47 23 00 79 90	ingvild.haugen@algeta.com

Show 155 Study Locations

Sponsors and Collaborators

Algeta ASA

Investigators

Study Chair:

Christopher Parker, M.D.

The Royal Marsden Hospital, UK

More Information

No publications provided

Responsible Party:	Algeta ASA, Oslo, Norway ( Peter Harris, CMO )
Study ID Numbers:	BC1-06
Study First Received:	June 17, 2008
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00699751 History of Changes
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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Neoplasm Metastasis

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones

Pharmacologic Actions
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasm Metastasis
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009