Your session is about to expire
← Back to Search
Enzalutamide + ADT + Radiation for Prostate Cancer (ENZARAD 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
Adequate liver function: Alanine transaminase (ALT) < 2 x ULN and bilirubin < 1.5 x Upper Limit of Normal (ULN), (or if bilirubin is between 1.5 - 2 x ULN, they must have a normal conjugated bilirubin)
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
ENZARAD Trial Summary
This trial is testing a new prostate cancer treatment.
Who is the study for?
Men over 18 with high-risk, localized prostate cancer that hasn't spread beyond certain lymph nodes. They must have a specific Gleason score or PSA level and be in good health with proper organ function. Participants need to start treatment within a week of joining and can't have had certain other cancers or treatments.Check my eligibility
What is being tested?
The trial is testing if adding enzalutamide to standard hormone therapy (LHRHA) improves outcomes for men undergoing radiation therapy for prostate cancer. Patients are randomly assigned to receive either enzalutamide or a conventional nonsteroidal antiandrogen along with LHRHA and targeted radiotherapy.See study design
What are the potential side effects?
Enzalutamide may cause fatigue, back pain, constipation, joint pain, hot flushes, diarrhea, dizziness, blood pressure changes, nausea, falls or fractures due to bone weakness. It might also affect liver enzymes and could lead to seizures in rare cases.
ENZARAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver tests are within the normal range.
Select...
I am 18 years old or older.
Select...
My blood tests show normal levels of hemoglobin, white cells, and platelets.
Select...
My kidneys work well enough (creatinine clearance over 30 ml/min).
Select...
I am fully active or can carry out light work.
ENZARAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Metastasis-free survival
Secondary outcome measures
Clinical progression-free survival
Health outcomes relative to costs (incremental cost effectiveness ratio)
Health related quality of life (HRQL)
+6 moreENZARAD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EnzalutamideExperimental Treatment3 Interventions
Enzalutamide 160 mg daily, by mouth, for 24 months from randomisation. All participants are treated with a LHRHA for 24 months from randomisation and external beam radiation therapy started approximately 16 weeks after randomisation (+/- brachytherapy boost)
Group II: Conventional Non-steroidal Anti-androgen (NSAA)Active Control3 Interventions
Conventional Non-steroidal Anti-androgen (NSAA), by mouth, for 6 months from randomisation.
All participants are treated with a LHRHA for 24 months from randomisation and external beam radiation therapy started approximately 16 weeks after randomisation (+/- brachytherapy boost)
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?
Australian and New Zealand Urogenital and Prostate Cancer Trials GroupOTHER
18 Previous Clinical Trials
5,770 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,727 Patients Enrolled for Prostate Cancer
National Health and Medical Research Council, AustraliaOTHER
165 Previous Clinical Trials
474,335 Total Patients Enrolled
1 Trials studying Prostate Cancer
1,071 Patients Enrolled for Prostate Cancer
Trans Tasman Radiation Oncology GroupOTHER
48 Previous Clinical Trials
15,827 Total Patients Enrolled
4 Trials studying Prostate Cancer
2,656 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can start the study treatment within a week of being chosen.My scans show cancer has spread, but no bone cancer is evident without specific tests.My prostate cancer has specific aggressive features.My cancer has spread to lymph nodes above my pelvis or outside it, confirmed by tests.My liver tests are within the normal range.My prostate cancer is high risk with a specific Gleason score, PSA level, or lymph node involvement.I haven't had serious heart problems in the last 3 months.I am sexually active and not using or willing to use birth control methods.I am 18 years old or older.I have a history of seizures or conditions that could lead to seizures.My blood tests show normal levels of hemoglobin, white cells, and platelets.I haven't had any cancer except skin cancer or some bladder cancers in the last 5 years.My kidneys work well enough (creatinine clearance over 30 ml/min).I am fully active or can carry out light work.I cannot undergo external beam radiotherapy due to health reasons.I have not had a fainting spell or mini-stroke in the last year.I have HIV under control with medication that won't interact with enzalutamide.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional Non-steroidal Anti-androgen (NSAA)
- Group 2: Enzalutamide
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.
Are patients presently able to enroll in this trial?
"According to the latest information available on clinicaltrials.gov, this research is not presently looking for patients. The trial was originally posted on 3/1/2014 and was most recently edited on 4/1/2021. Although this study is not seeking candidates at this time, there are 1387 other studies that are."
Answered by AI
Does LHRHA carry any risks for people?
"LHRHA receives a 3 on our team's safety scale at Power. This is due to the fact that LHRHA is in Phase 3 trials, signifying that there is both efficacy data as well as multiple rounds of safety data supporting its use."
Answered by AI
Are there similar ongoing research projects utilizing LHRHA?
"LHRHA is being studied in 103 different clinical trials, 30 of which are currently in Phase 3. Although many of the investigations into LHRHA's efficacy originated in Germantown, Tennessee, there are now 5,748 locations running these sorts of tests."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger