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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Algeta ASA
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00699751
First received: June 17, 2008
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

Alsympca is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.


Condition Intervention Phase
Hormone Refractory Prostate Cancer
Bone Metastases
Drug: Radium-223 dichloride (BAY88-8223)
Drug: Placebo
Phase 3

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:


Further study details as provided by Bayer:

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 ]

Enrollment: 921
Study Start Date: June 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radium-223 dichloride
Radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals
Drug: Radium-223 dichloride (BAY88-8223)
Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals
Other Name: Alpharadin
Placebo Comparator: Placebo
Isotonic saline for 6 IV administrations separated by 4 weeks intervals
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 Radium-223 dichloride 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 (Radium-223 dichloride:Placebo). The study treatment consists of 6 intravenous administrations of Radium-223 dichloride 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.

All patients received BSoC (Best Standard of Care).

  Eligibility

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

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 (External Beam Radiation Therapy) for bone pain

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 135 Study Locations
Sponsors and Collaborators
Bayer
Algeta ASA
Investigators
Study Chair: Christopher Parker, M.D. The Royal Marsden Hospital, UK
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00699751     History of Changes
Other Study ID Numbers: 15245, BC1-06
Study First Received: June 17, 2008
Last Updated: April 15, 2013
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department 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
United States: Food and Drug Administration

Keywords provided by Bayer:
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
Succinylcholine
Hormones
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 23, 2014