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A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-resistant Prostate Cancer and Men With Metastatic Prostate Cancer (ASPIRE-PCa)

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ClinicalTrials.gov Identifier: NCT02066961
Recruitment Status : Active, not recruiting
First Posted : February 20, 2014
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
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.

Condition or disease
Prostate Cancer Castration-resistant Prostate Cancer Metastatic Prostate Cancer

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 1533 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : December 31, 2013
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
Cohort 1
Subjects with biochemical failure experience after primary treatment and have high-risk disease
Cohort 2
Subjects with a medical diagnosis of castration-resistant prostate cancer
Cohort 3
Subjects with an initial diagnosis of metastatic prostate cancer



Primary Outcome Measures :
  1. Patterns of disease management [ Time Frame: up to 72 months ]
    Description of disease assessment methods, physician referral patterns and treatments

  2. Clinical outcomes [ Time Frame: up to 72 months ]
    Evidence of disease progression and development of symptomatic disease


Secondary Outcome Measures :
  1. Factors influencing physician treatment decisions [ Time Frame: up to 72 months ]
    Reason/s for treatment choices and trigger/s for treatment changes

  2. Documentation of healthcare resource utilization used to manage treatment-related complications [ Time Frame: up to 72 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be selected from the offices of either a medical oncologist, radiation oncologist, uro-oncologist, urologist, surgeon, or primary care physician.
Criteria

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

Exclusion Criteria:

  • Prior treatment of metastatic castration-resistant prostate cancer with systemic chemotherapy
  • Life expectancy of <1 year due to comorbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066961


  Show 95 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02066961     History of Changes
Other Study ID Numbers: ONC-MA-1001
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
metastatic prostate cancer
castration-resistant prostate cancer
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases