check_circleStudy Completed

Prostatic Neoplasms

PK in pts with HRPC & Skeletal Metastes

Trial purpose

Primary objective: To investigate the biodistribution, radiation dosimetry, and pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization], 6 weeks apart).
Secondary objectives: To determine the safety of IV injections of Xofigo after two separate injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w. (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect survival data at 6 and 12 months after the first injection

Key Participants Requirements

Sex

Male

Age

18 - N/A

Trial summary

Enrollment Goal
6
Trial Dates
July 2007 - December 2008
Phase
Phase 1
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom

Primary Outcome

  • Estimation of whole-body retention of radioactivity at each imaging time post-injection
    date_rangeTime Frame:
    1 week
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    Safety Issue:
    No
  • Estimation of the individual organ uptake/retention of radioactivity at each time-point post injection
    date_rangeTime Frame:
    1 week
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    Safety Issue:
    No
  • Estimate retention of administered radioactivity in blood
    date_rangeTime Frame:
    Up to 1 week
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    Safety Issue:
    No
  • Estimation of elimination of radioactivity in urine and faeces
    date_rangeTime Frame:
    2 days
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    Safety Issue:
    No
  • Calculation of estimated absorbed radiation dose to target organs
    date_rangeTime Frame:
    1 week
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    Safety Issue:
    No
  • Pharmacokinetics
    date_rangeTime Frame:
    1 week
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    Safety Issue:
    No

Secondary Outcome

  • Comparison of the biodistribution and dosimetry after the first and second injection
    date_rangeTime Frame:
    7 weeks
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    Safety Issue:
    No
  • Prostate specific antigen (PSA) response
    PSA decline, defined as the number of patients with a confirmed ≥50% reduction in PSA level after treatment with respect to the pre-injection PSA level and the time to PSA progression after PSA response
    date_rangeTime Frame:
    At baseline, before injections, and at 2 month intervals during the 12 month follow up period
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    Safety Issue:
    No
  • Survival
    date_rangeTime Frame:
    6 and 12 months after the first injection
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    Safety Issue:
    No
  • Adverse events
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    Yes
  • Laboratory variables; serum biochemistry and haematology
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    Yes
  • Vital signs
    Systolic/diastolic blood pressure, respiratory rate, heart rate and body temperature
    date_rangeTime Frame:
    12 weeks
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    Safety Issue:
    Yes
  • ECG (12 leads)
    Electrocardiogram (12 leads)
    date_rangeTime Frame:
    12 weeks
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    Safety Issue:
    Yes
  • Physical examination
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    Yes

Trial design

A Phase I, open-label, dosimetry, biodistribution and pharmacokinetic study of Alpharadin™ in patients with hormone refractory prostate cancer and skeletal metastases
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1