Enzalutamide for Prostate Cancer

Juravinski Cancer Centre, Hamilton, Canada
Prostate CancerEnzalutamide - Drug
What conditions do you have?

Study Summary

This trial is testing whether a new drug, enzalutamide, is more effective than a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 3 years

3 years
Adverse events
Clinical progression free survival time
Health-related quality of life (EORTC Core Quality of Life Questionnaire (QLQ C-30), Quality of Life Questionnaire for Prostate Cancer (PR-25), Euroqol 5 item preference-based measure of health (EQ-5 D-5L))
Healthcare resource cost-effectiveness (incremental cost effectiveness ratio)
Overall Survival Time
Prostate specific antigen progression free survival time

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

Conventional NSAA
1 of 2
1 of 2

Active Control

Experimental Treatment

1125 Total Participants · 2 Treatment Groups

Primary Treatment: Enzalutamide · No Placebo Group · Phase 3

EnzalutamideExperimental Group · 2 Interventions: Enzalutamide, LHRHA or Surgical Castration · Intervention Types: Drug, Drug
Conventional NSAAActiveComparator Group · 2 Interventions: LHRHA or Surgical Castration, NSAA · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

NCIC Clinical Trials GroupNETWORK
189 Previous Clinical Trials
143,716 Total Patients Enrolled
20 Trials studying Prostate Cancer
44,244 Patients Enrolled for Prostate Cancer
National Health and Medical Research Council, AustraliaOTHER
162 Previous Clinical Trials
468,274 Total Patients Enrolled
1 Trials studying Prostate Cancer
1,071 Patients Enrolled for Prostate Cancer
Australian and New Zealand Urogenital and Prostate Cancer Trials GroupOTHER
18 Previous Clinical Trials
5,471 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,744 Patients Enrolled for Prostate Cancer
Cancer Trials IrelandNETWORK
79 Previous Clinical Trials
22,483 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,213 Patients Enrolled for Prostate Cancer
Canadian Cancer Trials GroupNETWORK
116 Previous Clinical Trials
64,566 Total Patients Enrolled
10 Trials studying Prostate Cancer
6,825 Patients Enrolled for Prostate Cancer
University of SydneyLead Sponsor
178 Previous Clinical Trials
198,595 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,588 Patients Enrolled for Prostate Cancer
Christopher SweeneyStudy ChairDana Farber Cancer Institute and ANZUP
1 Previous Clinical Trials
1,100 Total Patients Enrolled
1 Trials studying Prostate Cancer
1,100 Patients Enrolled for Prostate Cancer
Ian DavisStudy ChairANZUP and Eastern Health Box Hill Hospital

Eligibility Criteria

Age 18+ · Male Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Is this trial popular in North American hospitals?

"The study is being conducted at 22 locations, with some notable hospitals being the Ottawa Hospital Cancer Centre, Hôpital Notre-Dame in Montreal, and Cross Cancer Institute in Edmonton." - Anonymous Online Contributor

Unverified Answer

Are people still signing up for this clinical trial?

"Enrollment for this particular trial has concluded. However, there are 1289 other prostate cancer trials and 103 Enzalutamide trials that are still recruiting patients." - Anonymous Online Contributor

Unverified Answer

What else do we know about Enzalutamide from other research?

"There are one hundred and three active clinical trials observing the effects of Enzalutamide. 30 of these studies have progressed to Phase 3. The primary research base for this treatment is Germantown, Tennessee; however, there are 5,748 total locations running Enzalutamide studies." - Anonymous Online Contributor

Unverified Answer

How many test subjects are in this experiment?

"At this time,this particular study is not seeking any more patients. The clinical trial was first posted on March 1st, 2014 and the most recent edit was made on October 7th, 2021. If you are looking for other trials, 1289 studies involving prostate cancer patients are recruiting and 103 research projects concerning Enzalutamide have open enrolment at the moment." - Anonymous Online Contributor

Unverified Answer

What is the FDA's official stance on Enzalutamide?

"Enzalutamide has undergone Phase 3 trials, meaning that there is evidence of its efficacy as well as multiple rounds of data affirming its safety. Because of this, our team at Power rates Enzalutamide a 3 on our safety scale." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.