Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008798

Trial Description

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Title

A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer

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Trial Acronym

PROSPER

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients
with non metastatic prostate cancer.

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Brief Summary in Scientific Language

[---]*

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Organizational Data

  •   DRKS00008798
  •   2015/06/23
  •   2013/12/03
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02003924  (ClinicalTrials.gov)
  •   MDV3100-14  (Medivation, Inc.)
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Health Condition or Problem studied

  •   Nonmetastatic Castration-Resistant Prostate Cancer
  •   Prostate Cancer
  •   Cancer of the Prostate
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Enzalutamide
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Metastasis Free Survival (MFS); time frame: ≥ 16 weeks

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Secondary Outcome

- Overall Survival (OS); time frame: ≥ 16 weeks
- Time to Pain Progression; time frame: ≥ 16 weeks
- Time to Opiate Use for Prostate Cancer Pain; time frame: ≥ 16 weeks
- Time to First Use of Cytotoxic Chemotherapy; time frame: ≥ 16 weeks
- Time to First Use of New Antineoplastic Therapy; time frame: ≥ 16 weeks
- Time to Prostate-Specific Antigen (PSA) Progression; time frame: ≥ 16 weeks
- FACT-P Global Score; time frame: ≥ 16 weeks
- Quality of Life as assessed by EQ-5D-5L and QLQ-PR25; time frame: ≥ 16 weeks

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Countries of Recruitment

  •   Argentina
  •   Australia
  •   Austria
  •   Belgium
  •   Brazil
  •   Canada
  •   Chile
  •   China
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Greece
  •   Hong Kong
  •   Ireland
  •   Italy
  •   Korea, Republic of
  •   Malaysia
  •   Netherlands
  •   New Zealand
  •   Poland
  •   Russian Federation
  •   Serbia
  •   Singapore
  •   Slovakia
  •   Spain
  •   Sweden
  •   Taiwan, Province of China
  •   Thailand
  •   Turkey
  •   Ukraine
  •   United Kingdom
  •   United States
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2013/12/31
  •   1560
  •   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 without
neuroendocrine differentiation, signet cell, or small cell features;

- Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH)
agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);

- Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;

- Progressive disease on androgen deprivation therapy at enrollment;

- PSA and the screening PSA assessed by the central laboratory (central PSA) should be
≥ 2 µg/L (2 ng/mL:

- PSA doubling time ≤ 10 months;

- No prior or present evidence of metastatic disease;

- Asymptomatic prostate cancer;

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

- Estimated life expectancy ≥ 12 months.

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Exclusion Criteria

- Prior cytotoxic chemotherapy;

- Use of hormonal therapy or biologic therapy for prostate cancer (other than approved
bone targeting agents and GnRH agonist/antagonist therapy) or use of an
investigational agent within 4 weeks of randomization;

- Known or suspected brain metastasis or active leptomeningeal disease;

- History of another invasive cancer within 3 years of randomization;

- Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10
g/dL (6.2 mmol/L) at screening;

- Total bilirubin ≥ 1.5 times the upper limit of normal;

- Creatinine > 2 mg/dL (177 µmol/L) at screening;

- Albumin < 3.0 g/dL (30 g/L) at screening;

- History of seizure or any condition that may predispose to seizure;

- Clinically significant cardiovascular disease;

- Gastrointestinal disorder affecting absorption;

- Major surgery within 4 weeks of randomization;

- Hypersensitivity reaction to the active pharmaceutical ingredient or any of the
capsule components, including Labrasol, butylated hydroxyanisole, and butylated
hydroxytoluene;

- Any concurrent disease, infection, or comorbid condition that interferes with the
ability of the patient to participate in the trial, which places the patient at undue
risk, or complicates the interpretation of data, in the opinion of the investigator
or medical monitor.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Medivation, Inc.
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Astellas Pharma Inc
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Medivation Clinical Trial Disclosure 
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  • start of 1:1-Block address public-contact
    • Medivation Clinical Trial Disclosure 
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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 .
  •   3
  •   2016/01/14


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