Brief Summary

To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline

Completed

Started May 2011

Typical duration for phase_2 prostate-cancer

Geographic Reach

4 countries

12 active sites

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

6 years study duration

First Submitted

Initial submission to the registry

February 21, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed

2 months until next milestone

Study Start

First participant enrolled

May 6, 2011

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2012

Completed

3.7 years until next milestone

Results Posted

Study results publicly available

April 6, 2016

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2017

Completed

Last Updated

October 2, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

February 21, 2011

Results QC Date

February 16, 2016

Last Update Submit

October 1, 2018

Conditions

Prostate Cancer

Keywords

bone turnoverhormone-naïveprostate specific antigenProstate Cancer

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25
A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 25 for any reason were treated as non-responders.
Baseline and Week 25

Secondary Outcomes (25)

Number of Participants With Adverse Events
From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)
Percent Change From Baseline in PSA
Baseline and Weeks 25, 49, 97, 169 and Week 265 (End of Study)
Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG)
Baseline and Weeks 25 and 49
Percent Change From Baseline in Androstenedione
Baseline and Weeks 25 and 49
Percent Change From Baseline in Dehydroepiandrosterone (DHEA)
Baseline and Weeks 25 and 49
+20 more secondary outcomes

Study Arms (1)

Enzalutamide

EXPERIMENTAL

Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.

Drug: Enzalutamide

Interventions

EnzalutamideDRUG

Oral

Also known as: Xtandi, MDV3100

Enzalutamide

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
Asymptomatic from prostate cancer
Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
PSA ≥ 2 ng/mL at screening

You may not qualify if:

Has previously or is currently receiving:
Hormonal therapy with intent to treat prostate cancer
Systemic glucocorticoids
Chemotherapy with the intent to treat prostate cancer
Opiate analgesics for pain from prostate cancer
Radiation therapy for treatment of the primary tumor or metastases
Has history of known or suspected brain or skull metastases or leptomeningeal disease
Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack
Clinically significant cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Astellas Pharma Inclead
Medivation, Inc.collaborator

Study Sites (12)

Site BE1003

Brussels, 1090, Belgium

Location

Site BE1001

Brussels, 1200, Belgium

Location

Site BE1002

Kortrijk, 8500, Belgium

Location

Site BE1005

Leuven, 3000, Belgium

Location

Site CZ3006

Olomouc, 77520, Czechia

Location

Site CZ3002

Prague, 16000, Czechia

Location

Site DK4001

Aarhus N, 8200, Denmark

Location

Site DK4004

Copenhagen, DK-2100, Denmark

Location

Site DK4002

Herlev, 2730, Denmark

Location

Site DE5005

Aachen, 51074, Germany

Location

Site DE5007

Bonn, 53111, Germany

Location

Site DE5003

Hanover, 30625, Germany

Location

Related Publications (3)

Trump D. Commentary on: "Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study." Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, Iversen P, Braeckman J, Heracek J, Baskin-Bey E, Ouatas T, Perabo F, Phung D, Hirmand M, Smith MR. Institut de Recherche Clinique, Universite Catholique de Louvain, Brussels, Belgium. Electronic address: bertrand.tombal@uclouvain.be. Aarhus University Hospital, Aarhus, Denmark. Herlev Hospital, Herlev, Denmark. AZ Groeninge Kortrijk, Kortrijk, Belgium. UZ Leuven, Leuven, Belgium. Klinik und Poliklinik fur Urologie, RWTH University Aachen, Aachen, Germany. Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. UZ Brussel, Brussels, Belgium. Univerzita Karlova v Praze, Prague, Czech Republic. Astellas Pharma Global Development, Leiden, Netherlands. Astellas Pharma Global Development, Northbrook, IL, USA. Medivation Inc, San Francisco, CA, USA. Massachusetts General Hospital Cancer Center, Boston, MA, USA: Lancet Oncol. 2014 May;15(6):592-600; doi: 10.1016/S1470-2045(14)70129-9. [Epub 2014 Apr 14]. Urol Oncol. 2016 May;34(5):248-9. doi: 10.1016/j.urolonc.2015.03.012. Epub 2015 Apr 30.
PMID: 25937426DERIVED
Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, Iversen P, Braeckman J, Heracek J, Baskin-Bey E, Ouatas T, Perabo F, Phung D, Baron B, Hirmand M, Smith MR. Long-term Efficacy and Safety of Enzalutamide Monotherapy in Hormone-naive Prostate Cancer: 1- and 2-Year Open-label Follow-up Results. Eur Urol. 2015 Nov;68(5):787-94. doi: 10.1016/j.eururo.2015.01.027. Epub 2015 Feb 14.
PMID: 25687533DERIVED
Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, Iversen P, Braeckman J, Heracek J, Baskin-Bey E, Ouatas T, Perabo F, Phung D, Hirmand M, Smith MR. Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study. Lancet Oncol. 2014 May;15(6):592-600. doi: 10.1016/S1470-2045(14)70129-9. Epub 2014 Apr 14.
PMID: 24739897DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title: Clinical Trial Disclosure
Organization: Astellas Pharma Global Devlopment, Inc.

Study Officials

Use Central Contact
Astellas Pharma Europe B.V.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 21, 2011

First Posted

February 23, 2011

Study Start

May 6, 2011

Primary Completion

July 29, 2012

Study Completion

April 27, 2017

Last Updated

October 2, 2018

Results First Posted

April 6, 2016

Record last verified: 2018-05

Locations

CZ(2)DK(3)DE(3)BE(4)

A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (25)

Study Arms (1)

Enzalutamide

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (25)

Study Arms (1)

Enzalutamide

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations