NCT03328364

Brief Summary

The purpose of this study is to provide real world data on treatment with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients. The primary purpose is to evaluate overall survival (OS) in mCRPC patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel) (post chemo patients). This study will also evaluate treatment duration with enzalutamide in patients pre- and post-chemo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2017

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

23 days

First QC Date

October 30, 2017

Last Update Submit

November 19, 2024

Conditions

Metastatic Castration Resistant Prostate Cancer

Keywords

enzalutamidemetastatic castration-resistant prostate cancerXtandiregistry based studyMDV3100mCRPC

Outcome Measures

Primary Outcomes (1)

  • Overall survival in metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide, who have previously undergone treatment with chemotherapy (docetaxel)

    Overall survival is defined as time from initiation to death of any cause.

    Up to a maximum of four years

Secondary Outcomes (2)

  • Treatment duration of enzalutamide in pre chemo mCRPC patients

    Up to a maximum of four years

  • Treatment duration of enzalutamide in post chemo mCRPC patients

    Up to a maximum of four years

Study Arms (2)

enzalutamide (mCRPC pre-chemo)

Patients treated with enzalutamide prior to chemotherapy

Drug: enzalutamide

enzalutamide and chemotherapy (mCRPC post chemo)

Patients treated with enzalutamide who have previously undergone treatment with chemotherapy (docetaxel)

Drug: enzalutamideDrug: docetaxel

Interventions

enzalutamideDRUG

oral

Also known as: Xtandi, MDV3100
enzalutamide (mCRPC pre-chemo)enzalutamide and chemotherapy (mCRPC post chemo)
docetaxelDRUG

intravenous infusion

enzalutamide and chemotherapy (mCRPC post chemo)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with mCRPC initiating treatment with enzalutamide pre- and post- chemo registered in the prostate cancer registry.

You may qualify if:

  • Chemo naïve mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration).
  • mCRPC patients treated with enzalutamide and ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration) post chemo.

You may not qualify if:

  • mCRPC patients previously exposed to Radium-223, abiraterone acetate and/or cabazitaxel for mCRPC (pre- and post chemotherapy).
  • Patients previously exposed to chemotherapy or abiraterone acetate+prednisolone in combination with GnRH analogue for hormone sensitive prostate cancer (HSPC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site SE46001

Malmo, Sweden

Location

Related Publications (1)

  • Alghazali M, Lofgren A, Jorgensen L, Svensson M, Fagerlund K, Bjartell A. A registry-based study evaluating overall survival and treatment duration in Swedish patients with metastatic castration-resistant prostate cancer treated with enzalutamide. Scand J Urol. 2019 Oct;53(5):312-318. doi: 10.1080/21681805.2019.1657494. Epub 2019 Sep 6.

    PMID: 31815592DERIVED

Related Links

MeSH Terms

Interventions

enzalutamideDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Medical Scientific Advisor

    Astellas Pharma a/s

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 1, 2017

Study Start

December 1, 2017

Primary Completion

December 24, 2017

Study Completion

December 24, 2017

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Locations

SE(1)