Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01618370
First received: June 11, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.


Condition Intervention Phase
Prostatic Neoplasms
Drug: Radium-223 dichloride (BAY88-8223)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Acute safety, variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: From baseline to 30 days post-treatment ] [ Designated as safety issue: Yes ]
    Safety variables to be analyzed during the treatment period include: ECOG PS, Skeletal-related events, Treatment emergent Grade 3-4 AEs, any grade of treatment-related AEs and SAEs, Safety laboratory tests including hematology and serum chemistry

  • Long-term safety, variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: From 30 days post-treatment up to 3 years ] [ Designated as safety issue: Yes ]
    Safety variables to be analyzed during the follow-up period include: Skeletal-related events, Treatment related AEs and SAEs, Secondary malignancies


Secondary Outcome Measures:
  • Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form) [ Time Frame: From baseline up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radium-223 dichloride Drug: Radium-223 dichloride (BAY88-8223)
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.

  Eligibility

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

Inclusion Criteria:

  • Age ≥18 years of age
  • Histologically or cytologically confirmed prostate cancer
  • Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)
  • Progressive disease is defined either by:

    • The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), PSA values from 3 assessments within the last 6 months must be provided; OR
    • In the absence of new bone lesions by 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met)
  • Life expectancy ≥ 6 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 2
  • Adequate hematological, liver, and renal function

    • Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L
    • Platelet count ≥ 100 x10^9/L
    • Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
    • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    • Creatinine ≤ 1.5 x ULN
    • Albumin > 25 g/L

Exclusion Criteria:

  • Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
  • Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
  • Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs (adverse events) due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)
  • Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets
  • Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
  • Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
  • Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
  • Presence of brain metastases
  • Lymphadenopathy exceeding 6 cm in short-axis diameter
  • Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
  • Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.
  • Any other serious illness or medical condition, such as but not limited to:

    • Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
    • Cardiac failure New York Heart Association (NYHA) III or IV
    • Crohn's disease or ulcerative colitis
    • Bone marrow dysplasia
  • Fecal incontinence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618370

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 216 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01618370     History of Changes
Other Study ID Numbers: 16216, 2012-000075-16
Study First Received: June 11, 2012
Last Updated: April 15, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Israel: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Austria: Austrian Federal Office for Safety in Health Care (BASG)
Mexico: COmisión FEderal para la Protección contra RIesgos Sanitarios = COFEPRIS
Russia: Ministry of Health of Russian Federation

Keywords provided by Bayer:
Radium 223
Alpharadin
Prostate Cancer
Bone metastases
Castrate resistant prostate cancer
Hormone refractory prostate cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
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 16, 2014