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Re-treatment Safety of Radium-223 Dichloride in Castration-resistant Prostate Cancer With Bone Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bayer
Information provided by (Responsible Party):
Bayer Identifier:
First received: August 30, 2013
Last updated: October 2, 2014
Last verified: October 2014

Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the initial course of radium-223 dichloride that led to the discontinuation of treatment. 40 Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg IV every 4 weeks.

The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit every 4 weeks, prior to receiving radium-223 dichloride.

After the end of treatment visit the subjects will enter the active follow up period. Related AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the first 12 weeks, then every 12 weeks for up to 2 years after the last dose of radium-223 dichloride.

After the 2 years of active follow-up, subjects will enter the long-term follow-up period and will be followed via telephone follow-up at 6-month intervals for late toxicities and survival up to 7 years after the last dose of radium-223 dichloride or until death.

Joint safety reviews will regularly take place to oversee safety of the subjects conducted at regular intervals.

An interim analysis of the safety data will be conducted during the study.

Condition Intervention Phase
Prostatic Neoplasms
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Re-treatment Safety Study of Radium-223 Dichloride in Subjects With Castration-resistant Prostate Cancer With Bone Metastases Who Received an Initial Course of Six Doses of Radium-223 Dichloride 50 kBq/kg Every Four Weeks

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of participants with either treatment-related AEs (adverse events) or SAEs (serious adverse events) [ Time Frame: Up to 7 months ] [ Designated as safety issue: Yes ]
  • Number of participants with Radium-223 dichloride-related SAEs in the active follow-up period [ Time Frame: Up to 2 years after last treatment ] [ Designated as safety issue: Yes ]
  • Change in complete blood count [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinue Radium-223 dichloride treatment due to treatment emergent AEs or death [ Time Frame: Up to 7 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Radiological progression free survival [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: No ]
  • Time to radiological bone progression [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: No ]
  • Pain improvement rate (defined as the number of subjects with pain improvement, divided by the total number of subjects evaluable for pain improvement) [ Time Frame: Up to 7 months ] [ Designated as safety issue: No ]
  • Time to pain progression (defined as the time in days from the start of treatment until occurrence of the first pain progression event) [ Time Frame: Up to 7 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 7.5 years ] [ Designated as safety issue: No ]
  • Time to first symptomatic skeletal event (SSE) [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: No ]
  • SSE-free survival [ Time Frame: Up to 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radium-223 dichloride
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)


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

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate at any given point in time during disease history
  • CRPC (castration-resistant prostate cancer) with clinical or radiologically confirmed bone progression
  • Treatment with 6 injections of radium-223 dichloride 50 kBq/kg and no evidence of progression to bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) during the first course of treatment
  • Signed written informed consent prior to participating in any study related procedures. Willing and able to comply with the protocol, including follow-up visits and examinations

Exclusion Criteria:

  • History of a radium-223 dichloride-related serious adverse event (SAE) or CTCAE Grade 3 or 4 adverse event (AE) during or after the initial course of radium-223 dichloride treatment that led to the discontinuation of treatment
  • Less than 30 days from the last dose administered in the initial course of radium-223 dichloride treatment
  • Visceral metastases 1 cm or greater in largest diameter and / or requiring local or systemic therapeutic intervention, as assessed by abdominal and pelvic magnetic resonance imaging (MRI) / computed tomography (CT) scan and / or chest X-ray within 30 days of the start of treatment
  • Lymphadenopathy with lymph nodes exceeding 6 cm in short-axis diameter and / or requiring local or systemic therapeutic intervention. Enlarged lymph nodes of any size if the lymphadenopathy is thought to be a contributor to concurrent hydronephrosis.
  • Current central nervous system (CNS) metastases
  • Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget's disease of bone)
  • Treatment with chemotherapy after the initial course of radium-223 dichloride treatment
  • Prior hemibody external radiotherapy
  • Prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186, or rhenium-188
  • Any other serious illness or medical conditions

    • Crohn's disease or ulcerative colitis
    • History of documented bone marrow dysplasia
    • Unmanageable fecal incontinence
  • Imminent or established spinal cord compression based on clinical findings and / or MRI that has not yet been treated
  • Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01934790

Contact: Bayer Clinical Trials Contact
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 32 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT01934790     History of Changes
Other Study ID Numbers: 16506, 2013-003046-17
Study First Received: August 30, 2013
Last Updated: October 2, 2014
Health Authority: Finland: Finnish Medicines Agency
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Norway: Norwegian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Neuromuscular Agents
Neuromuscular Blocking Agents
Neuromuscular Depolarizing Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 23, 2014