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Antiandrogen
Enzalutamide + ADT for Metastatic Prostate Cancer (ENZAMET Trial)
Phase 3
Waitlist Available
Research Sponsored by University of Sydney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male aged 18 or older with metastatic adenocarcinoma of the prostate
Adequate liver function: Alanine transaminase (ALT) < 2 x Upper Limit of Normal (ULN), bilirubin < 1.5 x ULN (or if bilirubin is between 1.5-2 x ULN, normal conjugated bilirubin required). ALT < 5 x ULN if liver metastases are present
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
ENZAMET Trial 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.
Who is the study for?
Men 18+ with newly diagnosed metastatic prostate cancer can join this trial. They must have certain levels of blood cells, liver and kidney function, and be able to start treatment within a week after joining. Those with specific heart conditions, other cancers in the past 5 years, or severe infections cannot participate.Check my eligibility
What is being tested?
The study is testing if enzalutamide is more effective than traditional anti-androgens when combined with hormone therapy or surgery for first line treatment of advanced prostate cancer. Participants will receive either enzalutamide or a non-steroidal anti-androgen as part of their therapy.See study design
What are the potential side effects?
Enzalutamide may cause seizures, high blood pressure, fatigue, back pain and constipation among other side effects. Hormone therapy might lead to hot flashes, reduced sexual desire and bone thinning.
ENZAMET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man over 18 with advanced prostate cancer.
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My liver functions within the normal range, even if I have liver metastases.
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My kidneys work well enough (creatinine clearance over 30 ml/min).
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My blood tests show normal levels of hemoglobin, white cells, and platelets.
ENZAMET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival Time
Secondary outcome measures
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))
+2 moreENZAMET Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EnzalutamideExperimental Treatment2 Interventions
Enzalutamide is 160 mg daily, by mouth, until clinical disease progression or prohibitive toxicity.
All participants are to receive standard background therapy with a LHRHA or surgical castration, as per standard of care. The choice of the LHRHA or surgical castration is at the discretion of the treating clinician.
Group II: Conventional NSAAActive Control2 Interventions
Conventional NSAA, by mouth until clinical disease progression or prohibitive toxicity.
All participants are to receive standard background therapy with a LHRHA or surgical castration, as per standard of care. The choice of the LHRHA or surgical castration is at the discretion of the treating clinician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved
Find a Location
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
165 Previous Clinical Trials
474,012 Total Patients Enrolled
1 Trials studying Prostate Cancer
1,071 Patients Enrolled for Prostate Cancer
Canadian Cancer Trials GroupNETWORK
124 Previous Clinical Trials
66,328 Total Patients Enrolled
11 Trials studying Prostate Cancer
7,135 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer has specific aggressive features.I have had hormone therapy for prostate cancer, but only in certain situations.I am a man over 18 with advanced prostate cancer.My liver functions within the normal range, even if I have liver metastases.I can start the study treatment within a week of being chosen.I have HIV but it's under control and my medication doesn't affect the trial drugs.I have had chemotherapy for prostate cancer, but no more than 2 rounds of docetaxel for advanced disease.I do not have any severe illnesses that could make treatment unsafe for me.My kidneys work well enough (creatinine clearance over 30 ml/min).I can care for myself but may not be able to do heavy physical work, especially if my prostate cancer has spread.I haven't had serious heart problems in the last 3 months.I am sexually active and do not use or cannot use birth control methods.I haven't had seizures, fainting, or mini-strokes in the last year.My blood tests show normal levels of hemoglobin, white cells, and platelets.I have not had any cancer except for skin cancer or some bladder cancers in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Enzalutamide
- Group 2: Conventional NSAA
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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