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ASPIRE-PCa: 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

Sponsor
Astellas Pharma Global Development, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02066961
Collaborator
(none)
1,533
Enrollment
93
Locations
70.4
Actual Duration (Months)
16.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Dec 31, 2013
    Actual Primary Completion Date :
    Nov 14, 2019
    Actual Study Completion Date :
    Nov 14, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Patterns of disease management [up to 72 months]

      Description of disease assessment methods, physician referral patterns and treatments

    2. Clinical outcomes [up to 72 months]

      Evidence of disease progression and development of symptomatic disease

    Secondary Outcome Measures

    1. Factors influencing physician treatment decisions [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 [up to 72 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Algiers Algeria 16005
    2 Site Algiers Algeria 16006
    3 Site Blida Algeria BP 190
    4 Site Buenos Aires Argentina 1060
    5 Site Cabal Argentina C1120AAT
    6 Site La Pampa Argentina 6300
    7 Site Port Macquarie New South Wales Australia 2444
    8 Site Tweed Heads New South Wales Australia 2485
    9 Site Kurralta Park South Australia Australia 5037
    10 Site Parkville Victoria Australia 3050
    11 Site Richmond Victoria Australia 3121
    12 Site Wien Austria 1090
    13 Site Belo Horizonte MG Brazil 30130-100
    14 Site Ijuí RS Brazil 98700-000
    15 Site Passo Fundo RS Brazil
    16 Site Porto Alegre RS Brazil 90110
    17 Site São Paulo SP Brazil 01246-000
    18 Site Caxias do Sul Brazil 95070-560
    19 Site Santo André Brazil 09060-650
    20 Site Granby Quebec Canada J2G8Z9
    21 Site Quebec Canada G1R 2J6
    22 Site Bogota DC Colombia 110221
    23 Site Bogotá DC Colombia 111321
    24 Site Cali Colombia 76001
    25 Site Cairo Egypt 11566
    26 Site Cairo Egypt 11796
    27 Site Cairo Egypt 12411
    28 Site Besançon France 25030
    29 Site Lille France 59037
    30 Site Nimes France 30029
    31 Site Pierre Benite France 69310
    32 Site Poitiers France 86021
    33 Site Saint Mande France 94163
    34 Site Suresnes France 92151
    35 Site Berlin Germany 14197
    36 Site Freiburg Germany 79106
    37 Site Hamburg Germany 20246
    38 Site Jena Germany 7743
    39 Site Nürtingen Germany 72622
    40 Site Rostock Germany 18107
    41 Site Ulm Germany 89075
    42 Site Jakarta Indonesia 10430
    43 Site Beer Ya'akov Zerifin Israel 70300
    44 Site Haifa Israel 31096
    45 Site Brescia Italy 25123
    46 Site Cremona Italy 26100
    47 Site Milano Italy 20133
    48 Site Orbassano Italy 10043
    49 Site Anyang Korea, Republic of 431-070
    50 Site Busan Korea, Republic of 602-714
    51 Site Busan Korea, Republic of 602739
    52 Site Incheon Korea, Republic of 405-760
    53 Site Seoul Korea, Republic of 110-746
    54 Site Seoul Korea, Republic of 137-701
    55 Site Seoul Korea, Republic of 139-872
    56 Site Suwon Korea, Republic of 442-723
    57 Site Beirut BA Lebanon 116301
    58 Site Beirut BA Lebanon 166830
    59 Site Durango Mexico 34000
    60 Site Amsterdam Netherlands 1105 AZ
    61 Site Nijmegen Netherlands 6525 GA
    62 Site Hamilton Waikato New Zealand 3204
    63 Site Christchurch New Zealand 8013
    64 Site Tauranga New Zealand 3140
    65 Site Tauranga New Zealand 622
    66 Site Muscat Oman
    67 Site Miraflores Lima Peru Lima18
    68 Site Lima Peru Lima 01
    69 Site Lima Peru Lima 18
    70 Site Makati Philippines 1229
    71 Site Pasig Philippines 1600
    72 Site San Juan Philippines 1502
    73 Site Riyadh Saudi Arabia 11411
    74 Site Singapore Singapore 119228
    75 Site Singapore Singapore 169610
    76 Site Singapore Singapore 258499
    77 Site Singapore Singapore 308433
    78 Site Vall d'Hebron 119-129 Barcelona Spain 8035
    79 Site Madrid Spain 28050
    80 Site Sabadell Spain 8208
    81 Site Guishan Township Taoyuan County Taiwan 333
    82 Site Kaohsiung Taiwan 807
    83 Site Kaohsiung Taiwan 81362
    84 Site Taichung Taiwan 40447
    85 Site Taipei Taiwan 10002
    86 Site Taipei Taiwan 11211
    87 Site Bangkok Thailand 10400
    88 Site Phayathai Thailand 10400
    89 Site Songkla Thailand 90110
    90 Site Hull United Kingdom HU17 8SX
    91 Site London United Kingdom SE1 9RT
    92 Site Newcastle upon Tyne United Kingdom NE7 7DN
    93 Site Sunderland United Kingdom SR4 7TP

    Sponsors and Collaborators

    • Astellas Pharma Global Development, Inc.

    Investigators

    • Study Director: Senior Medical Director, Astellas Pharma Global Development, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Global Development, Inc.
    ClinicalTrials.gov Identifier:
    NCT02066961
    Other Study ID Numbers:
    • ONC-MA-1001
    First Posted:
    Feb 20, 2014
    Last Update Posted:
    Dec 20, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Astellas Pharma Global Development, Inc.
    metastatic prostate cancer
    castration-resistant prostate cancer
    prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Dec 20, 2019