NCT01547299

Brief Summary

The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
2 countries

4 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

First Submitted

Initial submission to the registry

February 27, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

March 31, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 10, 2015

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

February 27, 2012

Results QC Date

March 30, 2015

Last Update Submit

October 19, 2018

Conditions

Prostate Cancer

Keywords

prostate cancerprostatectomyneoadjuvant

Outcome Measures

Primary Outcomes (1)

  • Pathologic Complete Response Rate

    Pathologic complete response rate was defined as percentage of participants with pathologic complete response. Pathologic complete response rate following triplet therapy (enzalutamide in combination with leuprolide and dutasteride) and enzalutamide alone when administered as neoadjuvant therapy for 180 days prior to prostatectomy in participants with localized prostate cancer. Pathologic complete response was defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen, as assessed by the local and central pathologist.

    Day 180

Secondary Outcomes (30)

  • Percentage of Participants With Positive Surgical Margins

    Day 180

  • Percentage of Participants With Extracapsular Extension: Local Review

    Day 180

  • Percentage of Participants With Extracapsular Extension: Central Review

    Day 180

  • Percentage of Participants With Positive Seminal Vesicles

    Day 180

  • Percentage of Participants With Positive Lymph Nodes

    Day 180

  • +25 more secondary outcomes

Study Arms (2)

Enzalutamide alone

EXPERIMENTAL

Enzalutamide 160 mg, orally, once daily

Drug: Enzalutamide

Enzalutamide & Leuprolide & Dutasteride

EXPERIMENTAL

Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily

Drug: EnzalutamideDrug: LeuprolideDrug: Dutasteride

Interventions

EnzalutamideDRUG
Also known as: MDV3100
Enzalutamide & Leuprolide & DutasterideEnzalutamide alone
LeuprolideDRUG
Enzalutamide & Leuprolide & Dutasteride
DutasterideDRUG
Enzalutamide & Leuprolide & Dutasteride

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to provide informed consent
  • years of age or older
  • Histologically confirmed adenocarcinoma of the prostate
  • Must be a candidate for radical prostatectomy and considered surgically resectable

You may not qualify if:

  • Stage T4 prostate cancer by clinical or radiologic evaluation
  • Treatment with an investigational agent within 4 weeks prior to randomization
  • Received therapy for other neoplastic disorders within 5 years
  • Hypogonadism or severe androgen deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Seattle, Washington, 98195, United States

Location

Unknown Facility

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamideLeuprolideDutasteride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsAzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
William Novotny, MD, Sr. Director, Clinical Development
Organization
Medivation, Inc.
william.novotny@medivation.com
415- 983-3066

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 7, 2012

Study Start

March 31, 2012

Primary Completion

November 30, 2013

Study Completion

November 30, 2013

Last Updated

October 23, 2018

Results First Posted

April 10, 2015

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests

Locations

US(2)CA(2)