Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006391

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006391
  •   2014/08/20
  •   2013/08/30
  •   no
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Secondary IDs

  •   2013-003046-17 
  •   NCT01934790  (ClinicalTrials.gov)
  •   16506  (Bayer)
  •   2013-003046-17 
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Health Condition or Problem studied

  •   Prostatic Neoplasms
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I-II
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Primary Outcome

- Number of participants with either treatment-related AEs (adverse events) or SAEs (serious adverse events); time frame: Up to 7 months
- Number of participants with Radium-223 dichloride-related SAEs in the active follow-up period; time frame: Up to 2 years after last treatment
- Change in complete blood count; time frame: Up to 2.5 years
- Number of participants who discontinue Radium-223 dichloride treatment due to treatment emergent AEs or death; time frame: Up to 7 months

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Secondary Outcome

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Countries of Recruitment

  •   United States
  •   Finland
  •   Germany
  •   Ireland
  •   Israel
  •   Italy
  •   Norway
  •   Spain
  •   Sweden
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2013/12/31
  •   40
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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

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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)

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer
    • Bayer Study Director 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.