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Completed

NCT Number: NCT02495974

European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.

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Key information

Conditions

Metastatic Castration Resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Site AT43001, Bregenz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men with mCRPC who have been prescribed enzalutamide as part of standard clinical practice
  • Germany only: Enzalutamide will be prescribed according to the current SmPC (Summary of Product Characteristics)

Exclusion criteria

  • Patients with the following will be excluded from study participation in France only:
  • Patients who have previously been treated with abiraterone acetate (Zytiga®) after docetaxel chemotherapy.
  • Patients who have previously been treated with cabazitaxel (Jevtana®)
  • Patients who have previously been treated with Xtandi®
  • Patients taking part in an interventional clinical trial

Treatment and study plan

Enzalutamide

Drug

oral

Other names: Xtandi

Primary outcomes

  1. Time to treatment failure (TTF)

    Time frame: up to 18 months

    Time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.

Secondary outcomes

  1. Time to prostate specific antigen (PSA) progression

    Time frame: up to 18 months

    Time from initiation of enzalutamide to the date of PSA progression. PSA progression is defined as a PSA rise of greater than or equal to 25% and an absolute increase of greater than or equal to 2 ng/mL.

  2. PSA response

    Time frame: up to 18 months

  3. Time to disease progression

    Time frame: up to 18 months

    Time from initiation of enzalutamide to the date of radiographic progression, PSA progression or clinical progression according to the investigator's assessment.

  4. Overall Survival (France only)

    Time frame: up to 18 months

    Time from initiation of enzalutamide to death or patient survival at the end of the study.

  5. Treatment duration

    Time frame: up to 18 months

  6. Reason for initiation of treatment with enzalutamide

    Time frame: up to 18 months

  7. Reason for enzalutamide discontinuation

    Time frame: up to 18 months

  8. Subsequent anti-neoplastic therapy for mCRPC

    Time frame: up to 18 months

  9. Time to opiate use

    Time frame: up to 18 months

  10. Pain assessed by Brief Pain Inventory Short Form (BPI-SF)

    Time frame: up to 18 months

    The questionnaire is a patient self-rating scale assessing the level of pain, effect of the pain on activities of daily living, and analgesic use.

  11. Quality of life of participants assessed using EQ-5D-5L

    Time frame: up to 18 months

    EuroQol5 dimension 5 level health state utility index - 5L (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. It is designed for self-completion by respondents comprising the following dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  12. Quality of life of participants assessed using FACT-P

    Time frame: up to 18 months

    Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a self reported instrument designed to assess patient function in physical, social/family, emotional, and functional well-being and further assesses items for prostate-related symptoms.

  13. Number of participants hospitalized

    Time frame: up to 18 months

  14. Number of visits to health care professionals

    Time frame: up to 18 months

  15. Safety assessed by reported adverse events

    Time frame: up to 18 months

  16. Safety assessed by modification of treatment with enzalutamide as a response to adverse events

    Time frame: up to 18 months

  17. Number of Deaths

    Time frame: up to 18 months

    Deaths defined as deaths due to any cause

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe Ltd.

Industry

Collaborators

  • Medivation, Inc.

Registry information

Official study title

A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Enzalutamide Treatment in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Acronym: PREMISE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 13, 2015
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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