Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006446

Trial Description

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Title

A Prospective, Longitudinal, Multinational, Observational Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk for Poor Clinical Outcomes After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-Resistant Prostate Cancer and Men With Metastatic Prostate Cancer at Initial Diagnosis

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Trial Acronym

ASPIRE-PCa

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this study is to describe patterns in disease management and to describe
clinical outcomes, as well as to identify factors influencing physician treatment decisions
including reason(s) for treatment choices and trigger(s) for treatment changes and to
document healthcare resource utilization used to manage treatment-related complications.

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Brief Summary in Scientific Language

Each subject will be followed from the time of enrollment for a minimum of 3 years and a
maximum of up to 6 years or until death, whichever comes first.

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Organizational Data

  •   DRKS00006446
  •   2014/11/06
  •   2014/02/18
  •   no
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Secondary IDs

  •   NCT02066961  (ClinicalTrials.gov)
  •   ONC-MA-1001  (Astellas Scientific & Medical Affairs, Inc.)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   Metastatic Prostate Cancer
  •   Castration-resistant Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Patterns of disease management; time frame: up to 72 months; Description of disease assessment methods, physician referral patterns and treatments
- Clinical outcomes; time frame: up to 72 months; Evidence of disease progression and development of symptomatic disease

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Secondary Outcome

- Factors influencing physician treatment decisions; time frame: up to 72 months; Reason/s for treatment choices and trigger/s for treatment changes
- Documentation of healthcare resource utilization used to manage treatment-related complications; time frame: up to 72 months

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Countries of Recruitment

  •   Algeria
  •   Argentina
  •   Australia
  •   Austria
  •   Brazil
  •   Canada
  •   Colombia
  •   Egypt
  •   France
  •   Germany
  •   Indonesia
  •   Israel
  •   Italy
  •   Korea, Republic of
  •   Lebanon
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Peru
  •   Philippines
  •   Saudi Arabia
  •   Singapore
  •   Spain
  •   Taiwan, Province of China
  •   Thailand
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/01/31
  •   2000
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- Diagnosis of prostate adenocarcinoma

- Will receive a new intervention at the time of study entry, for the treatment of:

- Biochemical failure after initial curative-intent surgery (radical
prostatectomy) or radiotherapy (external-beam radiation therapy, brachytherapy,
or both) and a PSA doubling time of one year or less or a confirmed PSA of ≥ 50
ng/mL (2 consecutive values) within 6 months prior to study entry; or

- Castration-resistant prostate cancer; or

- Metastatic prostate cancer at initial diagnosis of prostate cancer

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Exclusion Criteria

- Prior treatment of metastatic castration-resistant prostate cancer with systemic
chemotherapy

- Life expectancy of <1 year due to comorbidities

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Addresses

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    • Astellas Pharma Global Development, Inc.
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    •   [---]*
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    • Astellas Pharma Global Development, Inc.
    • Senior Medical Director 
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    • Astellas Pharma Global Development, Inc. 
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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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    •   [---]*
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Status

  •   Recruiting ongoing
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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 .
  •   11
  •   2016/07/17


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